Sterilization Enclosure For Surgical Instruments

ABSTRACT

A sterilization enclosure to be placed within a sterilizer, the sterilization enclosure defining an interior for accommodating at least one surgical instrument and maintaining sterility of the at least one surgical instrument after the sterilization enclosure is removed from the sterilizer. The enclosure comprising a light source and a transparent window. The light source to illuminate the interior and the transparent window positioned such that the interior and the at least one surgical instrument are visible through the transparent window. A process indicator that is either disposed within the interior or coupled to an external surface of the sterilization enclosure. The process indicator in fluid communication with the interior of the sterilization enclosure such that the process indicator is exposed to a sterilant agent disposed within the interior of the sterilization enclosure to measure a characteristic within the interior during a sterilization process.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/759,025, filed Mar. 9, 2018, which is a U.S. National StageApplication of International Patent Application No. PCT/US2016/051181,filed Sep. 10, 2016, which claims the benefit of U.S. Provisional PatentApplication No. 62/217,192, filed Sep. 11, 2015, and U.S. ProvisionalPatent Application No. 62/300,368, filed Feb. 26, 2016, all of which arehereby incorporated by reference in their entirety.

TECHNICAL FIELD

This disclosure is related to a sterilization enclosure configured todetermine whether instruments disposed within the container have beenexposed to threshold process conditions to ensure a desired level ofsterilization for those instruments.

BACKGROUND OF THE DISCLOSURE

Medical device manufacturers continuously investigate sterilizationsystems that efficiently sterilize surgical instruments for use byHealth Care Professionals (HCPs) during surgical procedures. Existingsterilization systems include containers configured to contain reusablesurgical instruments during a sterilization process and sealingly storethe sterilized instruments until they are required for a surgicalprocedure. The containers can comprise one or more apertures and filtersconfigured to permit sterilant agent(s) to enter the container whilepreventing contaminants from entering the same. The sterilizationsystems can further include sterilizer devices, which can have acompartment for receiving one or more containers. The sterilizer devicecan be configured to supply the compartment with pressurized and/orheated sterilant agent(s), such that the sterilant agent(s) enter thecontainers through the apertures to destroy micro-organisms on thesurgical instruments.

Containers can be disposed within the sterilizer device for periods oftime that are empirically determined as threshold process conditionsensuring a desired level of sterilization for the correspondinginstruments. In particular, the quantity of micro-organisms oninstruments can be measured before and after a sterilization process,and if the sterilization process achieves a desired reduction ofmicro-organisms on the instruments, the measured characteristics of thisprocess can be empirically determined as the threshold processconditions for ensuring the desired level of sterilization. Depending onthe desired level of sterilization and the instruments being sterilized,periods of time ranging from 0.1 to 48 hours can be empiricallydetermined as the threshold process conditions. The desired level ofsterilization can be a 3-log reduction in micro-organisms on the surfaceof instruments, a 6-log reduction, or various other amounts, with thetime of exposure being a threshold process condition that variesdirectly with the desired level of sterilization, such that longer timesof exposure can be required to disinfect the instruments to higherlevels of sterilization.

A drawback of these sterilization systems and the related sterilizationprocess is that the instruments may not be properly disinfected to thedesired level of sterilization, and the failure to achieve the desiredlevel of sterilization may not be immediately noticed by HCPs. Inparticular, apertures of the container can be impeded or the filter canbe occluded, such that the instruments inside the container may not beexposed to sterilant agent(s) and thus the instruments cannot be exposedto the threshold process conditions empirically determined to disinfectthese instruments to the desired level of sterilization. Put anotherway, while the container may have been quarantined inside thecompartment of the sterilizer device for the amount of time empiricallydetermined to expose the instruments to threshold process conditionsthat would achieve the desired level of sterilization, the instrumentsmay not have actually been exposed to sterilant agent(s) under thethreshold process conditions to disinfect the instruments to the desiredlevel of sterilization.

When the sterilization process has been completed, the sterilizedcontainers remain sealingly closed and stored in a sterile inventoryroom until the instruments are required for a surgical procedure and thesealingly closed container is delivered to an operating room where theHCP opens the container, and retrieves the instruments for use duringthe surgical procedure. Existing containers may not have any sensorsthat measure the characteristics within the containers during thesterilization process, and the containers may not have notificationdevices that communicate to HCPs the non-sterilized status or sterilizedstatus of the instruments. Thus, the hospital staff maintains records ofthe containers stored in the inventory room.

SUMMARY OF THE DISCLOSURE

A sterilization enclosure and associated methods are provided todetermine whether instruments disposed within the enclosure have beenexposed to threshold process conditions to ensure a desired level ofsterilization for those instruments and/or to provide an indicationand/or notification of the same.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, exemplary illustrations are shown indetail. Although the drawings represent examples, the drawings are notnecessarily to scale and certain features may be exaggerated orschematic in form to better illustrate and explain a particular aspectof an illustrative example. Any one or more of these aspects can be usedalone or in combination within one another. Further, the exemplaryillustrations described herein are not intended to be exhaustive orotherwise limiting or restricting to the precise form and configurationshown in the drawings and disclosed in the following detaileddescription. Exemplary illustrations are described in detail byreferring to the drawings as follows:

FIG. 1 is a perspective view of one non-limiting example of asterilization container having a body and a lid coupled to the body;

FIG. 2 is a perspective view of the body of FIG. 1 showing a surgicalinstrument disposed inside the body;

FIG. 3 is a perspective view of the inside of the lid of FIG. 1 and asensor module coupled to a filter frame coupled to the lid;

FIG. 4 is an enlarged cross-sectional view of a portion of the lid ofFIG. 1, showing the lid comprising a notification device;

FIG. 5 is an exploded view of the sensor module of FIG. 3;

FIG. 6 is a top perspective view of the sensor module of FIG. 3,illustrating the sensor module having a shell that is coupled to thefilter frame;

FIG. 7 is a cross-sectional view of the inside of the base and shell ofthe sensor module of FIG. 3;

FIG. 8 is a cross-sectional view of multiple sensors being mounted tothe base and shell of the sensor module of FIG. 3;

FIG. 9 is an enlarged cross-sectional view of the sensor module of FIG.3, illustrating the sensor module comprising a spring-loaded pin fordetecting the presence of a filter;

FIG. 10A is an exploded view of the filter frame and the lid of FIG. 3,with the sensor module removed to depict components of the filter frameholding the filter medium against the lid;

FIG. 10B is a bottom view of the filter frame of FIG. 10A, showing thefilter frame holding the sensor module and filter medium against the lidbefore a latch assembly is actuated to release the filter frame, sensormodule, and filter medium from the lid;

FIG. 10C is a bottom view of the filter frame of FIG. 10B, showing thelatch assembly being actuated to release the filter frame, sensormodule, and filter medium from the lid;

FIG. 10D is a bottom view of the lid of FIG. 10C, showing the sensormodule and filter frame being removed from the lid while the filtermedium remains positioned against the lid;

FIG. 10E is a bottom view of the lid of FIG. 10D, showing the filtermedium being removed from the lid after the sensor module and filterframe have been removed from the lid;

FIG. 11 is a block diagram of the electrical components of the sensormodule of FIG. 3;

FIGS. 12-14 are multiple cross-sectional views of the exemplary sensormodule of FIG. 8, showing the sensor module comprising the collimatorlenses immediately downstream of LEDs for using collimated light beamsto measure light absorption of sterilant gases indicative of theconcentration of the gases;

FIGS. 15-17 are multiple cross-sectional views of another exemplarysensor module, showing the sensor module encompassing the collimatorlenses immediately upstream of photodetectors for using collimated lightbeams to measure light absorption of sterilant gases indicative of theconcentration of those gases;

FIG. 18 is a schematic diagram of a portion of another exemplary sensormodule, showing the sensor module comprising multiple light controlelements, with the sensor module being configured to measure lightabsorption by multiple samples of one sterilant gas indicative of theconcentration of the gas;

FIG. 19 is a schematic diagram of a portion of yet another exemplarysensor module, showing the sensor module comprising a spectrometerconfigured to measure light absorption by multiple sterilant gasesindicative of the concentration of the gas;

FIG. 20 is a schematic diagram of a portion of still another exemplarysensor module, showing the sensor module comprising a FTIR spectrometerconfigured to measure light absorption by multiple sterilant gasesindicative of the concentration of the gases;

FIG. 21 is a perspective view of another example of a sterilizationcontainer, illustrating a sensor module coupled to an external surfaceof the container;

FIG. 22 is a perspective view of the sensor module spaced apart from thesterilization container of FIG. 21;

FIG. 23 is an exploded view of the valve of a portion of thesterilization container of FIG. 21, illustrating the containercomprising a normally closed valve for aseptically and removablycoupling the sensor module to the container;

FIG. 24 is a first perspective view of the valve of FIG. 23;

FIG. 25 is a second perspective view of the valve of FIG. 23;

FIG. 26 is a perspective view of the valve bezel plate of FIG. 23;

FIG. 27 is a plan view of the valve bezel plate of FIG. 26;

FIG. 28 is a perspective view of the outer surfaces of the sensor moduleof FIG. 23;

FIG. 29 is a perspective view of the inner face of the sensor module ofFIG. 23;

FIG. 30 is an exploded view of the sensor module of FIG. 28,illustrating the sensor module comprising a block and multiple sensors;

FIG. 31 is a cross-sectional view of the block internal to the sensormodule of FIG. 30;

FIG. 32A is a cross-sectional view of the sensor module of FIG. 30,illustrating the sensor module having a drain plug disposed in alowermost position on the sensor module when the sensor module ismounted to the container, such that condensate flows away from thesensors and exits the sensor module through the drain plug;

FIG. 32B is another cross-sectional view of the sensor module of FIG.30, illustrating the drain plug in a lowermost portion of the sensormodule when the sensor module is mounted to the container;

FIG. 33 is a block diagram of the complementary electrical componentsinternal to the valve and sensor module of FIG. 23;

FIGS. 34A and 34B are enlarged cross-sectional views of a portion of thevalve of FIG. 23 when the valve is in the closed state;

FIG. 34C is a perspective cross-sectional view of the container havingthe valve of FIGS. 34A and 34B in the closed state;

FIGS. 35A and 35B are enlarged cross sectional views of a portion of thevalve of FIG. 23 when the valve is in the open state;

FIG. 35C is a perspective cross-sectional view of the container havingthe valve of FIGS. 35A and 35B in the open state;

FIG. 36A is an exploded view of a portion of another example of asterilization container, illustrating a filter coupled to a normallyclosed valve that permits a sensor module to be aseptically andremovably coupled to the container;

FIG. 36B is a cross-sectional view of the sterilization container ofFIG. 36A, showing the normally closed valve positioned in a closed statewith a valve locking assembly being accessed from within an interior ofthe container when the container is opened to permit the valve to rotatefrom the closed state to an open state;

FIG. 36C is a cross-sectional view of the sterilization container ofFIG. 36B, showing the valve being rotated from the closed state to theopen state when container is opened and the valve locking assembly isaccessed from within an interior of the container;

FIG. 36D is a cross-sectional view of the sterilization container ofFIG. 36C, showing the valve positioned in the open state to permit thesensor module to fluidly communicate with the interior of the containerwhen the container is closed;

FIG. 36E is a cross-sectional view of the sterilization container ofFIG. 36D, showing the valve rotated from the open state to the closedstate, with the valve locking assembly preventing the valve fromrotating to the open state and fluidly communicating a contaminatedsensor module with the interior of the container without opening thecontainer and accessing the valve locking assembly within the interiorof the container;

FIG. 37 is an exploded cross-sectional view of the sensor module of thecontainer, the valve, and the filter of FIG. 36A;

FIG. 38A is a block diagram of another example of a sterilizationcontainer and sensor module that comprises a series of sensors internalto corresponding instruments being disinfected to measurecharacteristics of the saturated steam to which the instruments areexposed;

FIG. 38B is a block diagram of another example of a sterilizationcontainer and sensor module that comprises a single temperature sensorcoupled to the largest thermal mass within the container to measure thecharacteristics of the saturated steam to which the instruments areexposed;

FIG. 38C is a block diagram of still another example of a sterilizationcontainer and sensor module that comprises a single temperature sensorcoupled to the largest thermal mass that is disposed outside of thecontainer and within a sterilizer device to measure the characteristicsof the saturated steam to which the instruments are exposed;

FIG. 39 is a perspective view of another example of a sterilizationcontainer, illustrating a sensor module comprising a non-electric sensoraseptically and removably coupled to an external surface of thecontainer and a normally closed valve to fluidly communicate with theinterior of the container;

FIG. 40 is an illustration of the sensor module used in FIG. 39;

FIG. 41 is a schematic diagram of a sterilization container comprising atrapdoor mechanism in replacement of the normally closed valve;

FIG. 42A is a perspective view of another example of a sterilizationcontainer, illustrating a sensor module comprising a non-electric sensoraseptically and removably coupled to an external surface of thecontainer and a normally closed valve to fluidly communicate with theinterior of the container;

FIG. 42B is a flow chart of a method for retrieving the sterilizationcontainer of FIG. 42A containing a desired surgical instrument;

FIG. 43 is a perspective view of another example of a sterilizationcontainer comprising an airflow challenge cannula impeding airflow froman interior of the container to another embodiment of a sensor module;

FIGS. 44A and 44B are schematic diagrams of one exemplary notificationdevice having a button movable to a raised position to communicate thatthe instruments were exposed to the threshold process conditions forensuring that the desired level of sterilization for the instruments hasbeen achieved and a lowered position to communicate that the instrumentswere not exposed to the threshold process conditions;

FIGS. 45A and 45B are schematic diagrams of another exemplarynotification device having a button movable to a raised position forindicating the presence of a filter and a lowered position forindicating the absence of the filter;

FIG. 46 is an illustration of multiple filter detectors;

FIGS. 47A and 47B are schematic diagrams of an exemplary sensor assemblyhaving a sensor for detecting the presence of a non-electricnotification device comprising a conductive layer and emitting light toindicate the same;

FIGS. 48A and 48B are schematic diagrams of an exemplary sensor assemblyhaving a sensor for detecting the absence of a non-electric notificationdevice comprising non-conductive material and emitting light to indicatethe same;

FIG. 49A is an exploded view of another sensor module, taking the formof a phase change material (PCM) notification device coupled to one sidepanel of the sterilization container to position the PCM notificationdevice within the interior of the sterilization container;

FIG. 49B is an exploded view of the PCM notification device of FIG. 49Acoupled to one side panel of the sterilization container to position thePCM notification device external to the interior of the sterilizationcontainer;

FIG. 49C is a perspective view of the PCM notification device of FIG.49A integrated within the side panel of the sterilization container;

FIGS. 50A and 50B are exploded views of the exemplary PCM notificationdevice of FIGS. 49A-C, illustrating the PCM in a corresponding one ofupper and lower chambers of the PCM notification device;

FIG. 51A is a cross-sectional view of the PCM notification device,illustrating one portion of the PCM being unmelted and disposed in theupper chamber and another portion of the PCM being fully melted in thelower chamber;

FIG. 51B is a cross-sectional view of the PCM notification device,illustrating the entire amount of PCM being fully melted and transferredfrom the upper chamber to the lower chamber so as to indicate that theinstruments have been exposed to the threshold process conditions forensuring a desired level of sterilization;

FIG. 51C is a cross-sectional view of another exemplary PCM notificationdevice, illustrating the PCM notification device having a baffle in theform of a plate having a single orifice, with a portion of the PCM beingunmelted and positioned within an upper chamber above the baffle plateand a portion of the PCM being melted and transferred through theorifice into a lower chamber beneath the baffle plate;

FIGS. 52A-52F are various cross-sectional views of still anotherexemplary PCM notification device, illustrating the PCM notificationdevice comprising an hourglass configuration with a single tunedorifice, and the PCM in various positions;

FIG. 53 is a schematic diagram of another exemplary sensor module,illustrating the sensor module configured to measure the speed of soundthrough the sterilant gas within the container;

FIG. 54A is a perspective view of another exemplary sterilizationenclosure, illustrating the enclosure comprising a tray and a sterilebarrier wrap; and

FIG. 54B is a perspective view illustrating wrapping of the sterilebarrier wrap around the tray.

DETAILED DESCRIPTION

An exemplary sterilization enclosure to be used for measuringcharacteristics within the enclosure during a sterilization process todetermine whether surgical instruments disposed within the enclosurewere exposed to threshold process conditions to ensure a desired levelof sterilization for those instruments is described. The thresholdprocess conditions can be customized or empirically determined based onthe desired level of sterilization for a corresponding instrument usinga look-up table or other suitable algorithm.

While the term “decontamination” refers to destruction of any amount ofmicro-organisms, sterilization is a specific level of decontaminationthat has been empirically determined as an acceptable level ofdestruction of micro-organisms for certain applications. Examples of theacceptable sterilization process conditions can include a 3-logreduction in micro-organisms or 6-log reduction in micro-organisms.However, the desired level of sterilization can be higher or lower thanthese exemplary reductions in micro-organisms as necessary forparticular applications. Thus, while the disclosure is directed tovarious devices, systems, and methods for a sterilization enclosure usedto sterilize surgical instruments contained therein, it is contemplatedthat any number of these devices, systems, methods, or combinationsthereof can be used in various other suitable applications wheredecontamination is required, such as an entire room for medical ornon-medical applications. Non-limiting examples of non-medicalapplications requiring sterilization can include an ambulance, amanufacturing facility for computers, an aircraft, and a post office.

The phrase “surgical instrument” should be broadly understood, as usedherein, to refer to any instrument or device used for medical treatmentof any kind, including, but not limited to, patient care, diagnosis,therapy, or surgery.

The enclosure can comprise one or more sensors configured to measure thecharacteristics within the interior of the enclosure during asterilization process. Furthermore, the enclosure can further compriseone or more notification devices for communicating the status of theinstruments or the interior of the enclosure to a HCP. Further still,the notification devices may be configured for communicating thelocation of the enclosure to a HCP.

The sterilization enclosure should be broadly understood to encompassany structure or device that defines an interior configured to sealinglycontain therein one or more instruments during a sterilization processand maintain a sterile barrier until the enclosure is opened, such asfor retrieving the instruments within a sterile field of an operatingroom. In one embodiment, the term “enclosure” should be understood asdevice or apparatus capable of satisfying design and performancestandards for sterilization containment devices, ANSI/AAMI ST77.

While some exemplary enclosures comprise containers having rigid bodiesand lids coupled to the rigid bodies, other contemplated enclosurescomprise a sterile barrier wrap arranged to sealingly encompass one ormore instruments. The common characteristic of these enclosures are thatthey allow sterilant agent(s) into the enclosure during a sterilizationor decontamination process to affect the reduction of microbial level onthe instruments inside the enclosure and the enclosures maintain thereduced microbial level of the instrumentation after the enclosure isremoved from the sterilizer. Still other enclosure configurations arecontemplated. Furthermore, while the following exemplary sterilizationenclosures comprise various components for measuring and/or comparingcharacteristics within the enclosure during the sterilization processand still various other components for indicating and/or communicatingthe status of the instruments and other components, it is contemplatedthat the enclosure can comprise any combination of these components,including any combination of the described sensors and notificationdevices. Exemplary enclosures will be described below. It should beappreciated that any features contemplated with respect to one enclosuremay be combined with features described with respect to otherenclosures.

FIGS. 1-10E illustrate one exemplary sterilization enclosure in the formof a container 50. As shown in FIGS. 1 and 2, the container comprises abody 52 and a lid 70 removably attached to the body 52 for reusablemedical device sterilization. However, it is contemplated that theenclosure can include other forms. In this example, the body 52, the lid70, and various components attached to the lid, as described below, areformed from material that can be placed in a sterilizer device andwithstand exposure to sterilant agent(s) used to decontaminate surgicalinstruments to a desired level of sterilization, such as stainless steelor aluminum. In the illustrated embodiment, the body 52 is formed from anumber of panels that are arranged together to give the body a generallyrectangular shape. Of course, it is contemplated that the configurationof the body 52 is not particularly limited. A front panel 54 and a sidepanel 56 are identified in FIG. 2. Not seen are the back panel oppositethe front panel 54 and the second side panel opposite the illustratedside panel 56. Also not seen is the bottom panel that extends betweenthe front, back, and side panels. The bottom panel, it is understood,provides the body 52 with a closed bottom end. The top of the body 52 isopen. A handle 58, one seen in FIG. 1, is pivotally mounted to theoutside of each of the side panels 56. The body 52 may be shaped to holdone or more surgical instruments 60. The instruments 60 may be seated ona rack 62 that is removably seated in the body 52.

The lid 70 may be removably attached to the body 52 so as to cover theopen top end of the body 52. The lid 70, as seen in FIGS. 1, 4, and 10A,includes a plate 72 that forms the main body of the lid 70. The plate 72is configured to extend over essentially the whole of the open end ofcontainer body 52. A rim 74 extends around the outer perimeter of lidplate 72. The rim 74 defines a groove 76, and a compressible seal 78, asection of which is seen in FIG. 10A, is seated in the groove 76. Thecomponents forming container 50 are formed so that when the lid 70 isseated over the body 52, the top edges of the body, front, back, andside panels are received within the groove 76 so as to abut seal 78.

A latch 80 is mounted to the opposed sides of rim 74. The latches 80,when set, releasably hold the lid 70 to the body 52. The latches 80 arefurther designed so that when in the latched state, the latches 80 urgethe lid 70 against the body 52. This results in the seal 78 beingcompressed between the top edges of the body 52 and the lid rim 74. As aresult of this compression of the seal 78, the seal forms an airtightbarrier between the body 52 and the lid 70. The seal 78, whencompressed, is sufficient to prevent ingress of contaminants that wouldcompromise the sterilization condition of the contents within theinterior of the sterilization container.

In certain embodiments, a post 82, seen in FIG. 10A, may extend inwardlyfrom the body 52 facing surface of lid plate 72. The post 82 is formedwith a groove 83 that extends annularly around the post. In theillustrated example, the post 82 is centered on the center of the plate72.

The front panel 54, the side panel 56, the floor 57, the lid plate 72,or any combination thereof includes an aperture permitting sterilant gasto flow from the sterilizer into the interior of the container. Ofcourse, any numbers of apertures are contemplated, and these aperturesmay be located in any suitable location on the container. In thisexample, the floor 57 and the lid plate 72 includes a number ofapertures 86, two identified in FIG. 1. In one exemplary configuration,apertures 86 are arranged in a circular pattern around post 82. Theapertures are also spaced radially outwardly from the post 82. Ofcourse, other patterns of apertures are also contemplated.

In enclosures that comprise the sterile barrier wrap, the wrap isgenerally a porous material that allows ingress of the sterilant gas,but does not allow ingress of contaminants. The pores in the wrap may beconsidered as one example of apertures with characteristics similar tofilter medium 410 as described below.

In the illustrated embodiment, the lid plate 72 is further formed tohave two openings 88, one seen in FIG. 4. Openings 88 are diametricallyopposed to each other relative the post 82. A transparent dome 92 ismounted in each opening 88. The dome 92 can be comprised of a singlepiece of sterilizable material such as a polyphenylsulfone plastic. Onesuch plastic is sold under the brand name RADEL by Solvay AdvancedPolymers, of Alpharetta, Ga., United States. Referring to FIG. 4, thedome 92 is shaped to have a cylindrical stem 94. Stem 94 is the portionof the dome that is seated in opening 88. A head 95 is formed integrallywith and extends above the stem. Head 95 has a diameter greater thanthat of the opening 88 in which the dome 92 is seated. A retainer/seal96 is disposed around the portion of the stem 94 that projects inwardlyfrom the underside portion the lid plate 72. Here the “undersidesurface” of the lid plate 72 is understood to mean the surface of theplate facing the interior of the body 52. The “topside” surface isunderstood to mean the outwardly directed surface of the plate. Seal 96forms a gastight barrier between the lid plate 72 and the portion of thestem 94 seated in the opening 88.

From FIGS. 3 and 10A-10E it can be seen that a sensor module 102 and afilter frame 320 may be positioned adjacent to the aperture throughwhich sterilant gases ingress into the interior of the container. Inthis example, the sensor module 102 may be coupled to the filter frame320, which in turn is coupled to the underside portion of the lid plate72 that defines the apertures 86 through which sterilant gases ingressinto the interior of the container. Put another way, the sensor module102 may be coupled to the filter frame 320 in any suitable manner suchthat the position of the sensor module 102 is selectively fixed relativeto the filter frame 320. This configuration permits the sensor module tobe used for any suitable sterilization container configuration, becauseeven sterilization containers, which were not originally designed toinclude a sensor module, can have a filter frame that can be retrofittedwith the sensor module. Additionally, by coupling the sensor module tothe filter frame, where the filter frame is positioned adjacent to theapertures in the sterilization container, the sensor module is adjacentto the volume of sterilant agent(s) that enters the interior of thesterilization container. By monitoring the characteristics of sterilantagent(s) immediately adjacent to, or passing through, the filter medium,the sensor module advantageously can sense the changes through a controlsurface surrounding the interior of the sterilization container. Ofcourse, it should be appreciated that, through coupling of the sensormodule 102 to the filter frame 320, characteristics of other portions ofthe sterilant agent(s) can be monitored, such as volumes of sterilantagent(s) which are not adjacent to the filter medium and/or apertures ofthe filter container.

In other embodiments, the filter frame may be coupled to the sensormodule, which is in turn coupled to the portion of the containerdefining the apertures. In still other embodiments, each one of thesensor module and the filter module may be independently and directlycoupled to the portion of the container defining the apertures orvarious other portions of the container.

The filter frame 320 is configured to retain and press a filter medium410 in the interior of the container and against the front panel 54, theside panel 56, the floor 57, the lid plate 72 of the container, or anycombination thereof adjacent to apertures 86 formed in the same. As oneexample, the filter frame 320 holds the filter medium 410 against theunderside surface of the lid plate 72 so the filter medium 410 extendsunder and radially outwardly from the apertures. The filter medium 410is comprised of material that is permeable to sterilant agent(s), whichare in a gaseous state and are employed to sterilize the instruments 60disposed in the container and is sufficiently impermeable tocontaminants to maintain sterility within the interior of thesterilization container. The filter medium 410 may be dimensioned tocover the apertures 86 in the lid 70. Furthermore, the filter medium 410may comprise a center hole 412 positioned so that when the filter medium410 is disposed against the inner surface of the lid plate 72, the post82 may extend through the center hole 412. It should be appreciated thatthe sterilization container may include multiple filter frames, suchthat filter mediums may be positioned adjacent to any apertures includedwithin the sterilization container.

Continuing with the example shown in FIGS. 3 through 7, the sensormodule 102 may be configured to be coupled to the filter frame andretain one or more sensors configured to sense the characteristics ofthe sterilant agent(s) entering through the filter or residing withinthe interior of the sterilization container. In particular, the sensormodule 102 can include a housing, which in this example comprises a base104 and a shell 152. The base 104 may be generally plate-like in shapeand formed to define a through-opening 106. In the illustrated example,through-opening 106 subtends an area that is greater than 50% of an areawithin the perimeter of the base 104. The sensor module 102 is furtherconstructed so that opening 106 allows the flow of sterilant through thefilter frame 320. A ring 107 is formed integrally with and extendsupwardly from the inner-directed surface of the base 104. The ring 107extends upwardly from the inner edge of the base 104 that defines theouter perimeter of opening 106. A lip 108, seen best in FIG. 4,protrudes radially outwardly from and extends circumferentially aroundthe free end of ring 107. A rim 109 extends upwardly from the top-facingsurface of the lip 108. In the illustrated example, the inner circularsurface of rim 109 is located radially outwardly from the outer surfaceof the ring 107. The outer circular surface of the rim 109 is locatedinwardly from the outer radial surface of the lip 108.

Referring to FIG. 7, the ring 107 is formed to have a number of openings110. There are two openings 110, 110′. Openings 110, 110′ are spaced 90°apart from each other in the ring 107. There are two pairs of openings112. Each pair of openings 112 is located in the ring 107 so that thesection of the ring 107 that separates the individual openings in a pairof openings 112 is 180° from the center of the openings 110, 110′. Eachof the openings 112 is smaller in diameter than the openings 110, 110′.

A number of planar webs extend radially outwardly from the inner face ofthe ring 107, the face of the ring opposite the face of the ring thatdefines the perimeter of opening 106. Two essentially identical parallelwebs 114 extend outwardly from the section of the ring 107 that definesone of the openings 110. Each web 114 is spaced arcuately away from theadjacent opening 110. A web 116 and a web 118 extend away from the innerface of the ring face adjacent the opening 110′. Webs 116 and 118 areparallel with each other. Each web 116 and 118 is spaced arcuately awayfrom the associated opening 110′. Web 116 is essentially identical inshape to the web 114. Web 118 has a larger cross-sectional width thanthe associated web 116. Here the cross-sectional width is understood tobe the wall thickness of the corresponding webs. In other words, the web118 has a wall thickness that is greater than a wall thickness of theweb 116. The components forming the module housing are further formed sothat a bore 120 extends longitudinally through web 118. One end of bore120 opens into the inner face of the ring 116. Thus, bore 120 opens intothe inner surface of the ring 107. Bore 120 extends radially outwardlyfrom the ring 107 to the end of the web 118 that is radially spaced fromthe ring.

Two parallel webs 124 extend outwardly from the ring around each pair ofopenings 112. The webs 124 associated with each pair of openings 112 arelocated arcuately away from the opposed sides of the openings 112 withwhich the webs are associated. The webs 124 are arcuately spaced awayfrom the adjacent openings 112. A web 126 is located between and isparallel with each pair of openings 112. Each web 126 extends outwardlyfrom the section of the inner face of the ring between the openings 112with which the web is associated.

Two additional webs 128, 128′ extend outwardly from the inner face ofring 107. One web 128 is arcuately adjacent web 116. The second web 128is adjacent the web 124 closest to web 116. Webs 128 are parallel toeach other.

In the illustrated example, a terminal 132 is shown mounted to ring 107so as to extend into opening 106. Terminal 132 has a number of contacts(not identified). The terminal 132 is surrounded by an open-ended cage134. Cage 134 extends outwardly from the outer face of the ring 107 intothe opening 106.

In the illustrated example, indicia 138 are shown in FIG. 3 formed intothe outer face of the base 104. The indicia 138 include the text “LATCH”and an accompanying arrow.

Shell 152, as seen best in FIGS. 6 and 7, includes a top panel 154. Inthe illustrated example, the top panel 154 has a shape that generallymatches the shape of base 104, though the top panel 154 occupies aslightly smaller surface area. Transition panels 156 extend downwardlyand outwardly from the top panel 154. Side panels 158 (two identified)extend downwardly from the transition panels 156. The side panels 158are perpendicular to the top panel 154. Collectively, the base 104 andshell 152 are shaped so that the outer perimeter of the shell 152, asdefined by the side panels 158, matches the outer perimeter of thesensor module 102.

The shell 152 is further formed so there is a circular center opening162 in the top panel 154. Circular opening 162 is positioned so thatwhen the module 102 is assembled the circular opening 162 is concentric,with the base opening 106. The shell 152 is further formed to define anouter lip 165 and an inner lip 167 both seen best in FIG. 4. Both lips165 and 167 have exposed faces that are planar with the top surface ofthe shell top panel 154. Outer lip 165 has a top to bottom thicknessless than that of the adjacent section of the shell top panel 154. Theinner lip 167 is located radially inward from the outer lip 165. Innerlip 167 has a top to bottom thickness less than that of the outer lip.The inner perimeter of inner lip 167 defines the outer perimeter ofopening 162.

The components forming the sensor module are further constructed so thatwhen the shell 152 is secured to the base 104, the lip 108 integral withring 107 seats in the space below the outer lip 165 and rim 109 islocated slightly inwardly from the outer lip 165. An O-ring 148,identified in FIGS. 4 and 9, is seated between the lip 108 integral withring 107 and outer lip 165 integral with the shell top panel 154. Duringthe process of assembling the sensor module 102, the O-ring 148 iscompressed between the lips 108 and 165. The O-ring 148 thus provides aseal between ring 107 and the shell top panel 154.

Shell 152 is further formed to have two bores 164 open into the toppanel. Bores 164 are diametrically and symmetrically opposed to eachother relative to the center of opening 162. In the exposed face of toppanel 154, each bore 164 is surrounded by a counterbore 166. When thesensor module 102 is mounted to the container lid 70, each shell bore isdisposed under one of the domes 92 mounted to the lid. The componentsare dimensioned so that each counterbore 166 in the shell can receivethe stem 94 integral with the overlying dome 92.

Referring to FIG. 6, the two additional openings in the shell top panel154 are bores 170, which are spaced radially away from opening 162.Bores 170 are diametrically opposed from each other. Bores 170 arefurther positioned at a location such that, when the filter medium 410is disposed above the sensor module 102, the filter medium 410 extendsover the bores 170. As shown in FIG. 9, the shell 152 further comprisesa lip 172 projecting from the shell top panel 154 that forms each one ofthe bores 170. While this exemplary shell 152 comprises two bores 170that are identical to one another in their structural configurations,only one of the bores 170 is illustrated in FIG. 9.

A sleeve-like boss 168, one boss seen in FIG. 5, surrounds each bore 164and extends outwardly from the inner face of top panel 154. Asleeve-like boss 174, one boss seen in FIG. 5, surrounds each bore 170and extends outwardly from the inner surface of top panel 154. Bosses168 and 174 provide support for the components seated in bores 164 and170, respectively.

Referring to FIG. 5, shell 152 is further formed so that a sleeve 178 isformed integrally with one of the side panels 158 and extends inwardlyfrom the panel with which the sleeve is associated. In planesperpendicular to the major axis through the sleeve 178, the sleeve isrectangular in shape. Sleeve 178 is formed to define a closed-endedchamber 180 that extends axially through the sleeve 178. The side panel158 closest to the sleeve 178 is formed with a bore 182. Bore 182 opensinto chamber 180. While not seen, the interior surface of the shell 152that defines bore 182 may be formed with threading.

The exemplary sensor module 102 can further comprise a set ofseries-aligned cells 288 mounted in chamber 180. The cells 288 providepower to the components internal to the module that require electricalcurrent to function. The sensor module 102 can further comprise aninsulator 280 disposed adjacent to the closed end of the sleeve chamber180. Furthermore, the contact 286 can abut the positive terminal of thelead cell 288, and the contact 292 can abut the negative terminal of thetail cell. The sensor module 102 can further comprise a plug 296configured to hold the cells 288 in chamber 180. The plug 296 cancomprise an outer surface with a threading, such that the plug 296 canbe removably secured in a threaded bore 182. The sensor module 102 canfurther comprise a spring 297 located between the tail cell 288 and theplug 296 to urge the cells 288 against the contact 286 adjacentinsulator 280. An O-ring 298 can be disposed around plug 296. Thecomponents forming sensor module 102 are arranged so that the O-ring 298provides a seal between the plug 296 and the surface of the shell thatdefines bore 182.

The shell 152 is further formed so a triangular block 186 extendsinwardly from the corner where two of the side panels 158 meet. In theillustrated example, the corner from which the block 186 extends is thecorner adjacent the end of sleeve 178 that is spaced from bore 182. Anelongated bore 188 is formed in block 186. Bore 188 extends radiallyinwardly from planar inner face of the block 186. Bore 188 opens in theouter surface of the corner between the side panels 158 with which theblock is associated (see FIG. 7).

The shell side panels 158 comprise a groove 190 that extends inwardlyfrom the free ends of the panel. Groove 190 extends circumferentiallyaround the shell 152 immediately inwardly of the outer perimeter of theshell. A gasket 192 a portion of which is seen in FIG. 5, is disposed inthe groove 190. The gasket 192 extends a short distance outwardly awayfrom the shell 152. When the base 104 is secured to the shell 152, thegasket 192 is compressed between the base 104 and the side panels 158 ofthe shell 152. Gasket 192 thus provides a seal between the base 104 andthe side panels 158.

Not illustrated are the fasteners that hold the module base 104 to theshell 152. These fasteners extend through openings in the base intoclosed-ended bores internal to the shell side panels, base openings, andshell bores not illustrated. As a result of these fasteners holding thebase to the shell, O-ring 148 is compressed between the ring 107integral with the base 104 and the shell top panel 154. Gasket 192 iscompressed between the base 104 and the shell side panels 158.

It should be appreciated that other sensor module configurations arecontemplated for use in conjunction with the filter frame, so long asthey are operable to be coupled to the filter frame and retain a sensorthat is configured to sense the characteristics of the sterilantagent(s) passing through the filter or the characteristics of theinterior of the sterilization container or enclosure.

As best shown in FIG. 10A, the illustrated filter frame 320 includes acentrally-located hub 322. A rim 332 extends circumferentially aroundand is radially spaced away from the hub 322. Plural flexible,spring-like webs 330 extend between the hub 322 and the rim 332 so as toconnect the hub and rim together. The hub is formed to have a centeropening 328. The hub 322 has a ring 324 that extends downwardly from theinwardly directed surface of the hub. Ring 324 defines the perimeter ofthe opening 328. The filter frame 320 may assume other configurationssuitable to compress the filter adjacent the apertures of the lid plate.For example, the filter frame may assume any suitable shape anddimension so long as the filter frame is capable of biasing the filtermedia adjacent to the apertures so that a seal is formed by the filterframe.

In certain embodiments, the filter frame is further formed so that therim 332 is formed with an upwardly facing groove 334, seen in FIG. 4. Asmall lip 336, identified in FIG. 10A, projects radially outwardly fromthe portion of the rim 332 that defines the groove 334. When the sensormodule 102 is assembled, the filter frame lip 336 is sandwiched betweenthe rim 109 associated with ring 107 and the inner lip 167 integral withthe shell 152. The sandwiching of the lip 336 between the ring 107 andthe shell 152 holds the filter frame 320 to the rest of the module 102.

Of course, as mentioned above, other configurations of the filter frameand sensor module are contemplated which would be suitable to retain theposition of the filter frame relative to the sensor module. In otherwords, the sensor module may comprise a filter frame attachment devicethat is suitable to couple the sensor module to the filter frame. In theillustrated embodiment, the filter frame attachment device comprises thering 107 and the inner lip 167, but other structure is contemplated. Forexample, the filter frame attachment device may comprise one or morefasteners, an adhesive, or one or more magnets.

Still referring to FIG. 10A, a latch assembly 338 releasably holds thefilter frame 320 to the underside of the lid plate 72. The latchassembly 338 includes a cap 342 that is mounted to the frame hub 322.Cap 342 is disposed over ring 324. Two slides 344 are moveably mountedin the cap 342. The slides 344 are formed with features, not identified,that are arranged to seat in the groove formed in the post 82 so as tohold the filter frame and, by extension, the whole of the sensor module102 to the lid 70. Springs 346 hold the slides 344 in the cap 342 so theslides are normally in a position to engage the lid post 82. While notillustrated, one end of each spring 346 is connected to a first one ofthe slides 344. The opposed end of each spring 346 is connected to thesecond slide 344.

The slides 344 extend out of opposed openings 348 in the cap (oneopening 348 shown in FIG. 10A). Finger-force that is applied against theslides 344 displaces the slides from the locked state to the releasestate. When the slides are in the release state, the slides do notengage post 82. This allows for the removal of the sensor module 102from the lid 70. Of course, other configurations of the latch assemblyare contemplated.

A rigid disc 352 is disposed over the inner-directed face of the cap342. A circular seal 354 formed from elastomeric material is disposedover the outer face of disc 352. A gasket 356, which is also formed fromelastomeric, compressible material, is seated in the groove 334 internalto the frame rim 332. The components forming the filter frame 320 arearranged so that when the filter frame 320 is latched to the lid 70,seal 354 and gasket 356 press against the filter medium 410.Consequently, when container 50 is in this state, the center of thefilter is compressed between the lid 70 and seal 354. The perimeter ofthe filter is compressed between the lid 70 and gasket 356.

One or more sensors can cooperate with the container to measurecharacteristics within the interior of the container during asterilization process. The sensor module 102 described above may includea sensor configured to measure the sterilant gas and other vapors orgases entering and exiting the container through filter medium 410. Forother containers which may have additional locations for sterilant gasto enter and exit through filter medium 410, multiple sensors suitablylocated can work in combination with one another to measure allsterilant agent(s) and other vapors or gases entering and exiting thecontainer to effect decontamination of the instruments inside of thecontainer. These sensors can be disposed within the interior of thecontainer and/or coupled to an external surface of the container 50. Ina further embodiment, the sensor may form part of thecontainer/enclosure. More specifically, one or more of these sensors cancomprise one or more stand-alone devices and/or one or more integralcomponents of a sensor module that are: (1) disposed within thecontainer; (2) coupled to an external surface of the container but influid communication with the interior of the container; and/or (3)communicate with an airflow challenge cannula, which in turncommunicates with the interior of the container described herein.

Furthermore, the sensors can comprise any suitable configuration tomeasure different characteristics within the container during thesterilization process, and these characteristics can individually orcollectively ensure that the desired level of sterilization for theinstruments has been achieved. Examples of these configurations caninclude: (1) one or more optical sensor assemblies; (2) one or more gasconcentration sensors; (3) one or more temperature sensors; (4) one ormore pressure sensors; (5) one or more sound sensors; and/or (6) one ormore electromagnetic wave transmission sensors. These sensors can beused individually or collectively to measure the correspondingcharacteristics of sterilant gas concentration, temperature, and/orpressure within the container during the sterilization process.

Multiple sensors may be provided that are integral components of sensormodule 102. In this example, the sensors comprise: (1) one or more gasconcentration sensors, (2) one or more temperature sensors, and (3) oneor more pressure sensors, which collectively detect the concentrationsof sterilant gases, the temperature, and the pressure within thecontainer during the sterilization process. One or more of these sensorscan be configured to generate a signal indicative of the measurementtaken and communicate the same to a processor by wireless or wiredtransmission. While exemplary configurations of these sensors aredescribed below, other configurations of these sensors and/or any othersuitable sensors can be used to measure the characteristics within thecontainer during the sterilization process.

In one specific embodiment, the sensor module 102 may include a gasconcentration sensor, such as an optical sensor assembly configured tomeasure the absorption of light by the sterilant gas indicative of theconcentration of the sterilant gas within the interior of the containerand/or within the sterilizer device having the container disposedtherein. A processor can compare the measured light absorption with thethreshold process conditions empirically determined to ensure thedesired level of sterilization. To detect the concentrations of multiplesterilant gases within the interior of the container and/or thesterilizer device, two or more optical sensor assemblies configured tomeasure the concentrations of corresponding gases can be used. While thesensor module can comprise two optical sensor assemblies, any number ofoptical sensor assemblies can measure the concentrations of sterilantgases. In other embodiments, the gas concentration sensor may comprise acatalytic sensor, an electrochemical sensor, an infrared sensor, asemi-conductor sensor, and combinations thereof.

Referring to FIGS. 11-14, the sensor module 102 includes two opticalsensor assemblies 202 configured to determine a gas concentration withinthe interior of the sterilization container. In one embodiment, theoptical sensor assemblies 202 are configured to measure the absorptionof light indicative of the concentrations of a corresponding one of twosterilant gases within the container 50, such as water vapor andhydrogen peroxide. However, the optical sensor assemblies 202 can beconfigured to measure the absorption of light indicative of theconcentration of any suitable sterilant gas. In this example, eachoptical sensor assembly 202 is configured to emit a beam of light at awavelength through a sample of the sterilant gas within the container50. The amount of light that is absorbed by the corresponding sample ofsterilant gas is indicative of the concentration of that sterilant gaswithin that sample.

Each one of the optical sensor assemblies 202 is configured to measurethe light absorption by a sample of the sterilant gas along one or morelight paths within the container 50. The amount of light absorbed by thesterilant gas is indicative of the concentration of the sterilant gas.The accumulated length of the light paths directly correlates with theamount of sterilant gas exposed to the light and thus the accuracy inmeasuring light absorption and the corresponding concentration ofsterilant gas.

If the concentration of gas reaches a predetermined threshold condition,it can be determined that the desired level of sterilization for theinstruments was achieved. In an alternate example, a processor can beused to determine the curve defining the concentration of sterilant gasover time. The processor can calculate the area under the curve over aperiod of time and compare the area with corresponding threshold processconditions in a lookup table empirically determined to ensure a desiredlevel of sterilization for the instruments, as described in U.S. PatentApplication Pub. No. 2015/0374868, the disclosure of which is herebyincorporated by reference herein.

In one specific embodiment, each one of the optical sensor assemblies202 can include a light source configured to emit light across theopening 106 of the sensor module 102. More specifically, the lightsource can be an LED 204 configured to emit light at one or morepredetermined wavelengths. In one example, the LED 204 emits whitelight. The LED 204 is disposed between one of the webs 124 and thearcuately adjacent web 126. Each LED 204 is contained in a sleeve 206that is configured to hold LED 204 between the webs 124, 126. The LED204 is positioned so that the LED 204 emits light through the ringopening 112 located immediately inward of the webs 124 and 126.Alternative light sources other than LEDs may be used.

Each one of the optical sensor assemblies 202 may further comprise acollimator lens 208, which is configured to collimate, concentrate, ornarrow the light beam and direct the same through the correspondingopening 112. The beam of light, emitted by the LED, optionally in acollimated state, can be detected by a photodetector 239, which may becomparably smaller and thus less expensive than a photodetectorconfigured to detect a non-collimated beam of light. Additionally,another benefit of the more compact photodetector is that it can beattached to portions of the container 50 that cannot have comparablylarger photodetectors coupled thereto. While the collimator lens 208 isdisposed immediately downstream of the LED 204 as shown in FIG. 14,another exemplary sensor module, as shown in FIG. 15-17, may comprise acollimator lens 208 disposed immediately upstream of the photodetector239, thus providing a wider beam of light that can detect the absorptionof light by a larger sample of gases. While the collimator lens 208 maypermit the use of smaller photodetectors, it is contemplated that theoptical sensor assemblies may not include the collimator lens.

In the illustrated embodiment, the collimator lens 208 is coupled to thering 107 of the base 104. More specifically, the collimator lens 208 isdisposed between the webs 124 and 126 and located immediately downstreamor in front of the LED 204. The collimator lens 208 is located againstthe inner face of the ring 107 that defines the opening 112. The lens208 has a diameter greater than that of the opening 112. An O-ring 210is pressed between the section of the inner face of ring 107 thatdefines the opening 112 and the lens 208, such that the O-ring 210provides a seal around the opening 112. It is contemplated that anysuitable fasteners, seals and/or other mounting devices can integratethe collimator lens 208 within the optical sensor assembly 202.

As best shown in FIGS. 12 and 13, each one of the optical sensorassemblies 202 is configured to measure absorption of light indicativeof the concentration of gases by the sample of the corresponding gaseswithin two linear paths L1, L2 extending diametrically across theopening 106. In particular, each optical sensor assembly 202 may furthercomprise a prismatic reflector 218, which is coupled to a portion of thering 107 diametrically opposite to LED 204, the photodetector 239, andthe collimator lens 208 of the corresponding optical sensor assembly202, such that the beam of light is transmitted along one path L1 fromthe collimator lens 208 to the prismatic reflector 218. The prismaticreflector 218 is configured and positioned to reflect this light beamback across the opening 106 along the path L2 and into the ring opening112 adjacent to where the light was emitted. One such reflector is soldas the TECHSPEC Fused Silica Wedge Prism by Edmund Optis of Barrington,N.J., United States. However, the optical sensor assembly can includeany suitable prismatic reflector, and other embodiments of the opticalsensor assembly do not have a prismatic reflector. In this example, theprismatic reflector 218 is mounted immediately adjacent to the ringopening 110 opposite the ring opening 112 through which the light fromthe associated LED 204 is emitted. More specifically, the prismaticreflector 218 for a first one of the optical sensor assemblies 202 ismounted between the pair of webs 114, and the prismatic reflector 218for the second sensor assembly is mounted between webs 116 and 118. Aretaining ring 216 holds the prismatic reflector 218 between the webswith which the reflector is associated. The prismatic reflector 218 hasa face that subtends an area that is greater than the area of theadjacent window. An O-ring 220 is disposed between the perimeter sectionof the reflector and the portion of the inner ring that surrounds theopening 110. The O-ring 220 thus provides a seal between the ring 107and the prismatic reflector 218.

While specific arrangements of the optical sensor assemblies aredescribed above and illustrated in the figures, alternative arrangementsare contemplated.

Referring to FIG. 18, another exemplary optical sensor assembly 202′ canbe configured to measure light absorption indicative of theconcentration of sterilant gases along a multi-segmented path comprisingtwo or more linear paths. By joining multiple linear paths, the totallength of the ultimately detected light within the interior of thecontainer can be greater than if only one segment of light is measured.In other words, as compared to the two light paths L1, L2 shown in FIGS.12 and 13, three or more linear paths L1′, L2′, L3′ can provide a longerlight path for a larger sample of sterilant gas that absorbs more lightat a wavelength corresponding with the sterilant gas. The comparablylarger total amount of light absorption along a longer path can providea more accurate determination of the concentration of sterilant gas.

As shown in FIG. 18, the exemplary optical sensor assembly 202′comprises multiple elements that are similar to the elements of theoptical sensor assemblies 202 shown in FIGS. 14 and 17. However, incontrast to the previous examples, the optical sensor assembly 202′ canfurther comprise multiple light wave guides, light pipes, fiber opticelements, reflectors, or various other light control elements 203′configured to redirect the light beam along two or more distinct linearpaths to measure the concentration of a comparably larger sample ofsterilant gases. These distinct linear paths may not necessarily beparallel or aligned adjacent with one another.

The distinct linear paths may be disposed within the sensor module 102or within the container 50 to measure light absorption of the sterilantgas at various boundary conditions of the container 50. While the lightpaths L1, L2 of the previous examples shown in FIGS. 12 and 15 areconfigured to measure light absorption indicative of the concentrationof sterilant gas adjacent to the filter medium 410, the optical sensorassembly 202′ of FIG. 18 comprises multiple light control elements 203′configured to provide multiple light paths L L2′, L3′ adjacent to theinner surfaces 54 a′ of the panel 54′ of the container 50′. Similarsensor assemblies may be coupled to each panel of the container 50′. Inparticular, each one of the light control elements 203′ can be arrangedon an end section of each panel of the container 50′ opposite to an endsection of the same planar panel 54′ that carries the LED 204′, thephotodetector 239′, or the other light control element 203′. Morespecifically, because light travels in a linear direction, each one ofthe LED 204′, the two light control elements 203′ and the photodetector239′ can be arranged on a corresponding one of the four quadrants ofeach planar quadrilateral panel 54′, such that the linear paths L1′,L2′, L3′ for the light beams are disposed along or adjacent to the innersurface of each planar panel 54′ of the body 52, with the linear pathL2′ being disposed perpendicular to the linear paths L L3′. Moreover,these linear paths L L2′, L3′ may be disposed between the inner surfaceof the container 50′ and the rack or the instruments carried on therack, such that the optical sensor assemblies 202′ do not occupy spacerequired by the rack or the instruments.

The linear paths defined by the light control elements 203′ are notparticularly limited, and it is contemplated that the linear paths maybe directed along the internal perimeter of the container along an innerside of three panels 54, 56 of the container and around the surgicalinstruments contained therein. Moreover, the light control elements 203′may be arranged to define linear paths that are directed nearinstruments having recessed portions or other surface configurationsthat are difficult to sterilize. Furthermore, the light control elementsmay be integral parts of various other optical sensor assembliesconfigured to measure the concentration of sterilant gases.

Continuing with the example shown in FIG. 17, each one of the opticalsensor assemblies 202 further comprises the photodetector 239, asintroduced above. The photodetector 239 is located on the side of theweb 126 opposite the side adjacent to where the LED 204 is located. Thephotodetector 239 is thus located between the webs 124 and 126. Thephotodetector 239 is mounted to a circuit board 224, which is secured tothe free ends of the webs 124 and 126. The LED 204 is also shown mountedto the circuit board 224. A filter 228 is shown outwardly of the opening112 and between the webs 124 and 126. The lens 208 is shown betweenfilter 228 and the adjacent photodetector 239. Spacers 230 and 234 arealso located between the webs 124 and 126 to hold the filter 228 andlens 208 in the proper positions between the webs 124 and 126. An O-ring227 is located between the inner face of the ring 107 that definesopening 112 and the filter 228. The O-ring 227 is compressed between thering and the filter 228. The O-ring 227 thus provides a seal betweenring 107 and the filter 228.

In this example, each one of the optical sensor assemblies 202 isconfigured to determine absorption of light indicative of theconcentrations of a corresponding one of two different gases within thecontainer 50. In particular, the photodetector 239 integral with a firstone of the optical sensor assemblies 202 is configured to generate asignal representative of the absorption of light indicative of theconcentration of a first gas. For example, if one of the gases to bemeasured is steam, the associated optical sensor assembly 202 willinclude components configured to measure the absorption of light at the940 or 1360 nm wavelength, the wavelength of light absorbed by watervapor. Thus, in some examples, the filter 228 that is part of the firstoptical sensor assembly 202 filters out light other than light of thewavelength that is absorbed by the first gas. Moreover, thephotodetector 239 integral with the second optical sensor assembly 202can be configured to generate a signal representative of theconcentration of a second gas different from the first gas. If thesecond gas that is being measured is vaporized hydrogen peroxide, thesecond optical sensor assembly 202 is assembled from components able togenerate signals representative of the absorption of light at the 245 or1420 nm wavelength. These wavelengths of light are absorbed by hydrogenperoxide. The filter 228 that is part of the second optical sensorassembly 202 filters out light other than light of the wavelength thatis absorbed by the second gas.

While each one of the dedicated optical sensor assemblies 202, 202′ ofcorresponding FIGS. 12-18 are configured to measure the absorption oflight indicative of the concentration of only one sterilant gas, anoptical sensor assembly configured to simultaneously measure lightabsorption indicative of the concentrations of multiple sterilant gasescan be used in combination with a processor and a lookup table todetermine whether the instruments inside the container have been exposedto a desired level of sterilization, i.e., whether the exposure time toa certain concentration of gas correlates to the desired level ofsterility.

Referring to FIG. 19, another exemplary sensor module 102″ comprises anoptical sensor assembly comprising a micro-spectrometer 202″. One suchmicro-spectrometer 202″ is sold under the brand name C12666MA byHamamatsu, of Bridgewater, N.J., United States. However, the opticalsensor assembly can include any suitable micro-spectrometer, and otherembodiments of the optical sensor assembly may not have amicro-spectrometer. Spectroscopy can analyze a narrower bandwidth oflight frequencies that facilitates the ability to measure at single ormultiple absorption peaks for various gases, as compared to the opticalsensor assemblies 202, 202′ of FIGS. 12-18. In particular, spectroscopyalso yields a measurement having a selectable and more precise bandwidthtolerance as compared to conventional filters which have bandwidths oftypically +/−10 nm or +/−5 nm). Also, spectroscopy allows measurementsat multiple nominal frequencies, which can be used to measure a targetgas to improve accuracy. As one example, both 940 nm and 1360 nmwavelengths can be used to determine water vapor concentration, and theprocessor 384 (FIG. 11) can use these measurements to calculate theconcentration of sterilant gas based on the Beer-Lambert law. Thus, aspectrometer can be used to measure the light intensity of a light beamat multiple target wavelengths and analyze only a wavelength range ofinterest. Non-limiting examples of wavelength ranges can include 245nm+/−0.5 nm, 245 nm+/−1.0 nm, or 1360 nm+/−1 nm. In other words, forexamples using the spectrometer, the light does not have to beaccurately filtered by the filters of the previous example, and themeasurement accuracy around the target wavelength is programmable andcalculated from a data curve generated during measurement.

The micro-spectrometer 202″ is configured to measure the concentrationsof multiple sterilant gases thus providing a comparably more compactsensor module 202″ than sensor modules having more than one opticalsensor assembly. Specifically, this micro-spectrometer 202″ may comprisea light source, such as LED 204″, configured to emit light having arange of distinct wavelengths and, optionally, a collimator lens 208″configured to collimate and direct the light beam along a first linearpath L1″. Furthermore, while the previous exemplary optical sensorassembly 202′ of FIG. 18 comprises two light control elements 203′ forre-directing the light beam through sterilant gases along a secondlinear path L2′ between the two light control elements 203′ and thenre-directing the light beam along the third linear path L3′ parallel toand aligned with the first linear path L1′, the present exemplarymicro-spectrometer 202″ of FIG. 19 may further comprise one lightcontrol element 203″ that comprises a single retro-reflector configuredto receive the light beam from the first linear path L1″ and re-directthe light beam along a second linear path L2″ parallel to and alignedwith the first linear path L1″, thus resulting in a higher absorptionvalue and increased resolution as compared to a single path for a lightbeam that is not re-directed by a retro-reflector. The higher absorptionvalue and the increased resolution, as provided by the re-directed lightbeam, can be particularly useful in measuring water vapor when there isa lack of humidity, because humidity can have a substantial effect onthe sterilization efficacy of the sterilant gas. Of course, the numberof retro-reflectors, collimator lenses, and other components are notparticularly limited, and any number may be suitably arranged to provideenhanced accuracy in determining the sterilization process conditionswithin the container.

The position of the micro-spectrometer, light source, andretro-reflectors is not particularly limited, so long as themicro-spectrometer is arranged to receive light emitted from the lightsource after the light has passed through a sufficient volume of gaspresent within the interior environment of the sterilization container.For example, the micro-spectrometer, light source, and retro-reflectorsmay be coupled to the lid, side panels, or bottom of the container, ormay be coupled to the filter frame.

Furthermore, the sensor module 102″ may further comprise another lightcontrol element 203″ that comprises a Thermal infrared spectroscopy(TIR) collector, which is configured to receive the light beam from theTIR optic guide and narrow the same. The sensor module 102″ of FIG. 19can comprise a single transducer 239″ configured to receive the narrowedlight beam from the TIR collector and thus provide a signal andcorresponding data for measuring the concentrations of multiplesterilant gases. The transducer 239″ can be an IR spectrometerconfigured to send a signal indicative of measured data to the processor384 (see FIG. 11) by wireless or wired transmission.

Referring to FIG. 20, another exemplary FTIR micro-spectrometer 202′″uses Fourier Transform Infrared (FTIR) spectroscopy to simultaneouslycollect high spectral resolution data over a wide spectral range andprovide data to the processor 384 for determining the concentrations ofmultiple sterilant gases. This FTIR micro-spectrometer 202′″ providesbenefits similar to those provided by the micro-spectrometer 202″ ofFIG. 19. In particular, the FTIR micro-spectrometer 202′″ can measureand analyze a narrower bandwidth of light that facilitates the abilityto measure at absorption peaks for various gases, as compared to theoptical sensor assemblies 202, 202′ of FIGS. 12-18. Moreover, aretro-reflector can be configured to re-direct a light beam so as toincrease light absorption and resolution, as compared to a single pathfor a light beam that is not re-directed by a retro-reflector. Thehigher absorption value and the increased resolution, as provided by there-directed light beam, can be particularly useful in measuring watervapor when there is low humidity, because humidity can have asubstantial effect on the efficacy of the sterilant gas. The FTIRmicro-spectrometer 202′″ of FIG. 20 has multiple components, which aresimilar to components of the optical sensor assembly 202″ of FIG. 19.However, while the optical sensor assembly 202″ of FIG. 19 uses thermalinfrared spectroscopy (TIR) spectroscopy to measure data correspondingwith the concentrations of sterilant gases, the FTIR micro-spectrometer202′″ is an optical sensor assembly using FTIR spectroscopy to measurethe data. In one example, the processor 384 (FIG. 11) can analyze thisdata in combination with data received from temperature sensors andpressure sensors to determine the sterilant gas concentration or steamsaturation state. In other examples, more than one retro-reflector canbe disposed between the LED 204′″ and the transducer 239′″ so as toincrease the cumulative length of the light path and thus increase thelight absorption and resolution of the micro-spectrometer 202′″.

As shown in FIG. 11, the processor 384 may receive a signal from thetransducer 239′″, which in this example comprises a FTIR spectrometer.The processor 384 may generate an interferogram 205′″ by makingmeasurements of the light energy signal at many discrete positions 207′″of a moving mirror integral to the FTIR spectrometer. The Fouriertransform can convert the interferogram into an actual spectrum. Fouriertransform spectrometers offer significant advantages over dispersive(i.e. grating and prism) spectrometers. In particular, the FTIRspectrometer can monitor all wavelengths simultaneously throughout theentire measurement and increase signal-to-noise ratio, as compared tothe optical sensor assemblies 202, 202′ of FIGS. 12-18.

It should be further appreciated that suitable spectrometers other thanthose explicitly contemplated above may be utilized, and thosespectrometers may use any suitable spectroscopy technique in order toanalyze the light absorption data or other characteristics of thesterilant gases within the container.

Any of the gas concentration sensors, such as one of the optical sensorassemblies 202″, 202′″, can be used in combination with a temperaturesensor and/or a pressure sensor, as described below, to measure thesteam saturation state, as described below, or other characteristicswithin the container during the sterilization process for determiningwhether a desired level of sterilization for the instruments has beenachieved.

Referring to FIGS. 5 and 8, the sensor module 102 can further include atemperature sensor 240. The exemplary temperature sensor 240 comprises aclosed-ended tube 242 formed from material that is thermally conductiveand will not corrode when exposed to the sterilant gases introduced intothe sterilization container. One non-limiting example of the tube 242 isformed from aluminum and mounted in bore 120 so the closed end of thetube 242 is located adjacent the void space defined by ring 107. Afitting 246 holds the tube 242 to web 118. An O-ring 244 is disposedaround the head of the fitting 246 adjacent the end of the web 118spaced from ring 107. The O-ring 244 provides a seal between the web 118and the fitting 246.

The temperature sensor 240 can include a temperature sensitivetransducer disposed in the closed-ended tube 242. In some examples, thetransducer can be a thermistor. The temperature sensor 240 can beconfigured to send a signal indicative of temperature to the processor384 (FIG. 11) by wireless or wired transmission. It should beappreciated that any suitable type of temperature sensor may beutilized, including, but not limited to, thermocouples, resistivetemperature devices, infrared sensors, bimetallic devices, phase changeindicators, etc. Furthermore, the temperature sensor may be positionedin any suitable location relative to the sterilization container, solong as the temperature sensor is able to sense the temperature withinthe interior environment of the sterilization container.

Continuing still with the previous examples of FIGS. 5 and 8, the sensormodule 102 may further comprise the pressure sensor 256. In theillustrated embodiment, the pressure sensor 256 comprises a smallopen-ended housing 258 mounted to the module shell so as to be disposedagainst the face of block 186 integral with shell 152. The housing 258is sealingly mounted to the shell 152 so that bore 188 opens into theopen end of the housing. Furthermore, while fluids may enter the housing258 as condensate during a sterilization process or as fluidscorresponding with washing or cleaning of the container, the housing 258and components therein can be arranged in a configuration to permitthose fluids to drain out of the housing 258, such that the accuracy ofthe pressure sensor 256 is maintained over time.

The pressure sensor 256 may further comprise two pressure-sensitivetransducers 260, 262 contained within the housing 258. In some examples,both pressure-sensitive transducers 260, 262 are capacitor typetransducers. The capacitance of each transducer 260, 262 varies as afunction of the ambient absolute pressure. A first one of thetransducers 260 provides relatively accurate measurements of ambientabsolute pressure for relatively high pressures, such as a pressureabove a minimum pressure of 20 to 50 Torr. A second one of thetransducers 262 provides relatively accurate measurements of absolutepressure for relatively low pressures. For the purposes of thisdescription, a relatively low pressure is a pressure below a maximumpressure of between 10 and 100 Torr. The transducer 262 providesaccurate measurements of pressure to a pressure of 0.5 Torr, moreideally to at least 0.2 Torr and more ideally still to 0.05 Torr. Notshown are the conductors that extend from transducers 260 and 262through housing 258. Also not shown are the components that sealinglyholds housing 258 against block 186.

The type of pressure sensors that may be used in conjunction with thesterilization container is not particularly limited, so long as thepressure sensor is capable of determining the pressure within theinterior of the sterilization container. Without being limited, thepressure sensor may comprise a force-type pressure sensor, a resonantfrequency pressure sensor, or any other suitable pressure sensor. Whenthe sensor module is used for monitoring a sterilant agent like steam,it is preferred to use a pressure sensor that determines the absolutepressure of the steam so that characteristics such as the saturationstate of the steam is more readily determined. The pressure sensor 256can be configured to send a signal indicative of the measured pressureto the processor 384 (FIG. 11) by wireless or wired transmission.

Processor 384 may further comprise a memory, which stores the operatinginstructions for the processor 384, including empirical data directed tovarious measured characteristics, such as benchmark light absorptionvalues, temperature thresholds, pressure thresholds, and/or colorchanges empirically determined to ensure the desired level ofsterilization. Also stored in the memory are the data acquired by andgenerated by the processor 384 during the operation of the sensor module102.

An on/off switch 382 is shown connected to the processor 384. While notseen elsewhere in the drawings, the on/off switch 382 is typicallymounted to either the base 104 or ring 107.

The processor 384 is shown as outputting the signals that result in thecurrent flow through the LEDs 268, 270 to actuate the same andcommunicate various characteristics of the container 50 based on inputreceived from the one or more sensor modules, such as the gasconcentration sensor, the temperature sensor, the pressure sensor, othercharacteristics of the sterilant gas, or any combination thereof. Theprocessor 384 may be further in communication with the notificationdevice described herein through wired or wireless transmission.

Referring to FIG. 8, a circuit board 278 is shown mounted to the freeend of webs 124. While not seen, the circuit board 278 is the componentinternal to the module to which the processor 384 and other components(not illustrated) that actuate the module are mounted.

Referring to FIG. 11, while the cells 288 are shown as just beingconnected to the processor 384, it is understood that the cells 288 maybe connected to other power-consuming components of the sensor module102. Often these connections are through one or more voltage regulatorsnot illustrated in the figures. Terminal 132 is shown as being connectedto the processor 384. This connection allows instructions to be writtento the processor 384 and the data stored in the memory integral with theprocessor to be read out. In some examples, as a result of connectionsbetween some of the pins integral with terminal 132 and the cells 288,charging current is applied to the cells over the terminal 132.

In certain embodiments, the sterilization container may further comprisea filter presence detector 209, as shown in FIG. 11. By detecting thepresence of the filter medium 410, the HCP can confirm that that filteris present in the container before initiating the sterilization process.In this example, the filter presence sensor comprises two conductivepins 276. As shown in FIG. 9, each one of the pins 276 is mounted to themodule shell 152 and is moveably mounted in a separate one of theopenings 170 formed in the shell 152. The sterilization containerfurther includes a biasing member configured to move the conductive pins276 toward the filter medium 410, which urges the pin outwardly so thatthe ends of the pins project away from the upwardly facing surface ofshell top panel 154. The biasing member can be a helical spring 279around the pin 276. At least a portion of the lid plate 72 can be madeof electrically conductive material, and the filter medium 410 can becomprised of a non-conductive material. The presence of thenon-conductive filter medium 410 can open a circuit comprising theprocessor 384, such that the processor 384 can determine that the filteris present and thus proceeds with a method for determining whether theinstruments were exposed to the threshold process conditions to ensurethe desired level of sterilization. Also, in response to determiningthat the filter is present (based on the input of the filter presencedetector 209), the processor 384 can generate a signal indicative of thesame. The processor 384 can send this signal by wireless or wiredtransmission to the notification device, which in one form comprises theLEDs 268, 270, being further configured to communicate to an HCP thatthe filter is present in the module. However, as will be describedbelow, the notification device can be any suitable mechanism capable ofnotifying the HCP that the filter is present in the module, such asaudible notification device. If the filter medium 410 has not beenmounted in the container 50, the pins 276 contact the conductive lidplate 72 to close the circuit comprising the processor 384, such thatthe processor 384 determines that the filter medium 410 is not presentand sends a signal to the notification device to communicate the absenceof the filter medium 410. Other types of filter presence indicators arealso contemplated, such as mechanical or electromechanical filterpresence indicators.

Referring to FIGS. 2 and 10A-10E, use of the sterilization enclosure,such as container 50 typically starts with the rack 62 on which one ormore instruments is loaded within the container body 52. A filter medium410 is placed against the inner surface of the lid plate. The filterframe 320 is then placed over the filter medium 410. In this step, thecap 342 is fitted over and latched to post 82 to hold the filter frame320 to the lid 70. As a result of this latching, the filter medium 410is biologically sealingly compressed between the lid and filter frame320. In the illustrated embodiment, the sensor module 102 is coupled tothe filter frame 320. As such, attachment of the filter frame over thefilter medium 410 also fixes the position of the sensor module 102relative to the sterilization container 50. In another embodiment, thesensor module is constructed as an integral part of the filter frame 320to both sealingly compress the filter medium 410 against the container50 and position the sensors adjacent to the filter medium 410 asdescribed above.

During the step of latching sensor module 102 and filter frame 320 tothe lid 70, the indicia 138 prompts the individual performing thisprocess to position the module so the module is correctly orientedrelative to the lid 70. When the module 102 is so oriented, in oneembodiment, each LED 268 and 270 is disposed under a separate one of thetransparent domes 92.

A user input device, such as on/off switch 382, may be engaged toactuate the sensor module 102. In response to the actuation of thesensor module 102, the processor 384 initially evaluates the filterpresence indicator, such as the circuit associated with pins 276, todetermine whether or not the filter is present. In the illustratedembodiment, if the circuit is open, the pins 276 are abutting thenon-conductive filter medium 410. Accordingly, if the circuit is open,the processor 384 considers the sensor module 102 to be in a state inwhich the module is disposed below a filter medium 410. The processordoes not take any additional action. If, alternatively, the filterpresence indicator does not identify that a filter is located above thesensor module 102, the pins 276 press against the lid plate 72, which iscomprised of conductive material. The abutment of the pins 276 againstthe lid plate 72 therefore closes the circuit formed by the pins 276.Accordingly, if processor 384 determines the circuit is in this state,the processor 384 considers the container 50 to be in the state in whicha filter is not disposed between the lid 70 and the sensor module 102.When the processor 384 determines that the container 50 is in thisstate, the processor 384 provides an indication of this state to theHCP. In some examples, the processor 384 provides this indication withthe notification device, such as by alternatively cycling the LEDs 268,270 on and off.

In an alternate example, one of the pins could be removed and thecircuit continuity with the lid can be facilitated through an electricalpath established when the sensor module is mounted or latched to thelid. The remaining pin, in conjunction with the electrical pathestablished to the lid when it is mounted or latched, would function asthe filter presence monitor as described above. In yet another example,the filter presence monitor could be used in conjunction with the filterholder and without the other sterilization process sensors contained inthe sensor module described above.

Assuming the filter medium 410 is properly mounted to the lid 70 (orother portion of the container that includes one or more apertures), thelid 70 is latched over the open end of the container body 52. Thecontainer 50, with one or more instruments 60 disposed in the interiorof the container 50, is placed in a sterilizer and subjected to thesterilization process.

During the sterilization process, the one or more sensor assemblies 202,202′, 202″, 202′″, 240, 256 measure the characteristics within theinterior of the container and, optionally, generate signals indicativeof the same. Based on these signals, the processor 384 compares themeasured characteristics with the threshold process conditions todetermine whether or not a desired level of sterilization for theinstruments has been achieved. A “validated sterilization process” isunderstood to be a sterilization process that, based on past testing, isknown to sterilize a particular instrument to a desired level ofsterilization that essentially ensures any microbial material on theinstrument would be innocuous. A surgical instrument is often consideredsterilized if the instrument has a desired level of sterilizationcorresponding to a 6-log reduction in micro-organisms. This means thatthe microorganism population on the instrument was likely reduced by atleast 99.9999%. U.S. Patent Publication No. 2015/0374868, herebyincorporated by reference, provides an explanation of how to obtainenvironmental measurements for a validated sterilization process.

If as a result of the evaluation, the processor 384 may determinewhether one or more instruments were exposed to threshold processconditions that ensure a validated sterilization process, the processoractuates the notification device, such as LED 270. However, it will becontemplated that the processor can actuate the LED 270 or othernotification devices when the instruments are exposed to other desiredlevels of sterilization. In addition, or as an alternative to relying onthe notification device, the HCP may look at the one or more sensorsincluded with the container to determine whether one or more instrumentswere exposed to threshold process conditions to verify a validatedsterilization process.

In one possible implementation, the green light emitted by the LED 270,which is visible through the overlying dome 92 (FIG. 4), provides thepersonnel with the notice that the instruments in the container 50 havebeen exposed to the threshold process conditions that ensure the desiredlevel of sterilization. Alternatively, as a result of the evaluation,processor 384 may determine that one or more instruments 60 were notexposed to threshold process conditions that ensure a validatedsterilization process or other desired level of sterilization. If theprocessor 384 makes this determination, the processor actuates LED 268.The red light emitted by LED 268 provides an indication that even thoughone or more instruments were subjected to a sterilization process, theinstruments were not exposed to threshold process conditions that ensurethe desired level of sterilization. This indication serves as a cue thatfurther action needs to be taken to sterilize the instruments.

In another possible implementation, the notification device couldutilize alternative notification modalities, such as by emitting anoise, to alert the HCP that the instruments within the container haveor have not reached the desired level of sterilization.

While the first exemplary sterilization container comprises sensors thatare typically disposed within the container, a second exemplarysterilization container can comprise sensors that are disposed outsideof the container, yet fluidly communicate with the interior of thecontainer. The sensors may be coupled directly to an external surface ofthe container or be integral components of a sensor module removably andaseptically coupled to the container. It should be understood that anyof the sensors described above as being disposed within the interior ofthe sterilization container could alternatively be disposed outside thecontainer, yet communicate with the interior of the container.

FIGS. 21 and 22 illustrate the second exemplary sterilization container430 and a sensor module 570, which is removably coupled to the container430 and contains one or more sensors that fluidly communicate with thecontainer 430 as will be described below. In this example, the sensormodule 570 is mounted to the outside of the container 430. In certainconfigurations, internal to the container is a valve 450 (See FIG. 23).Sensor module 570 is mounted to the container 430 adjacent the valve450.

The sensor module 570 and container 430 may be arranged such thatremovably coupling the sensor module 570 to the container 430 opens thevalve 450, such that sensors 620 (see FIG. 30) disposed within thesensor module 570 fluidly communicate with the interior of the containerwhen the valve 450 is in the opened state. In turn, the sensor module570 and the container 430 may be arranged and configured such thatremoving the sensor module 570 from the container 430 closes the valve450, such that the fluid communication between the surrounding outsideenvironment of the container 430 and the interior of the container isnot established when the sensor module 570 is removed. In other words,the sensor module 570 and the container 430 are advantageously arrangedsuch that the sensor module 570 can be decoupled from the container 430without compromising the sterility of the interior of the container 430and the instruments therein.

In the illustrated embodiment, container 430 includes a body 432 towhich a lid 440 is removably attached. Body 432, like body 52, is formedfrom a number of panels that are arranged together to give the body agenerally rectangular shape. A front panel 434 and a side panel 436 areidentified in FIG. 21. Not seen are the back panel opposite the frontpanel 434 and the second side panel opposite the illustrated side panel436. Also not seen is the bottom panel that extends between the front,back, and side panels. It is understood that bottom panel provides thebody 52 with a closed-bottomed end. In other examples, the bottom panelcould contain a filter and apertures similar to the filter and apertureson the lid, which allow sterilant gas to flow in and out of thecontainer. The top of the body 52 is open. A handle 58, one seen in FIG.21, is pivotally mounted to the outside of each of the side panels 436.Body 432 has a void space dimensioned to hold one or more surgicalinstruments. In another example, the body 432 can also include a rackthat supports the instruments.

In the illustrated example, the valve 450 is mounted to the illustratedside panel 436 of the container body 432. The side panel 436 to whichthe valve is mounted includes a through opening 438, identified in FIG.23. It is contemplated that the valve, and associated components,including the sensor module, may be coupled to any suitable location onthe container, such as the lid, side panels, bottom panel, or otherportions of the container. Furthermore, the sterilization container mayoptionally include two or more valve and sensor module assemblies.

Lid 440 is structurally similar to and functionally identical to thepreviously described lid 70 of the first exemplary container 50illustrated in FIG. 3. Not seen are the components that latch the lid440 to the top of the body 432 and that form a seal between the lid 440and the body 432. The lid 440 is formed with apertures 86. Not seen isthe filter, essentially filter medium 410, and the filter frame thatremovably holds the filter to the inner-directed face of the lid 440.

Referring to FIGS. 22-25, the valve 450 may be coupled to the body 432of the container 430 and rotatable between an open state and a closedstate. In this example, the valve 450 can comprise a valve cap 452 thatis mounted to the body 432 against the inner surface of the associatedside panel 436. The valve cap 452 can be generally planar in shape. Morespecifically, in this example, the valve cap 452 generally comprises atruncated disc. The valve cap 452 can have an inner face 454, which isdirected toward the adjacent inner surface of the side panel 436. Thevalve cap 452 further can comprise a rim 460 that extendscircumferentially around the inner face 454 and toward the adjacentsurface of the side panel 436. The inner face 454 can comprise acircular groove 456 spaced radially inward from the rim 460.

The inner face 454 may comprise four ribs 458, which are disposed in andextend outwardly from the base of groove 456. These ribs 458 areequangularly spaced apart from each other. Each rib 458 can have aconvex surface directed toward the side panel 436. More specifically,each rib 458 may extend arcuately from the base of the groove 456, suchthat the convex surface gradually curves toward the side panel 436 to acrest and then curves arcuately back to the base of the groove 456. Eachone of the ribs 458 may be disposed entirely within the groove 456. Eachone of the ribs 458 may extend across an entire cross-sectional width ofthe groove up to the inner perimeter of the rim 460. Of course, otherconfigurations of the inner face are also contemplated.

The valve cap 452 further may comprise at least one hole 464 thatfluidly communicates with the interior of the sterilization container.The hole 464 may extend from the inner face 454 to the opposed outerface 455. In the illustrated example, the valve 450 comprises four holes464 equidistantly spaced from the center of the inner face 454.Furthermore, these holes 464 are equi-angularly spaced apart from oneanother. The inner face 454 of the valve cap 452 comprises four grooves466 that surround a corresponding one of the four holes 464. The innerperimeter of each groove 466 is spaced radially outwardly from the outerperimeter of the corresponding hole 464.

The rim 460 may comprise an outer perimeter and a bore 468 that extendsradially inwardly therefrom. While not seen in the Figures, bore 468opens into the space immediately in front of the cap inner face 454.

The valve cap 452 may be coupled to the inner face of the side panel 436of the body 432, such that the holes 464 in the valve cap 452 areequidistantly spaced radially outward from a central axis of the opening438 in the adjacent side panel 436. Not illustrated is the assembly thatholds the valve cap 452 static to the side panel 436. In some examples,the valve comprises fasteners (not shown) that extend through bores inboth the side panel 436 and the valve cap 452 so as to hold the valvecap 452 to the side panel 436. Also, it should be understood that thevalve cap 452 is secured to the side panel 436 so there is no gapbetween these components. In many examples, a gasket (not shown) may bedisposed between the panel and the exposed face of the cap rim 460. Thefasteners that hold the valve cap 452 to the side panel 436 can compressthis gasket between the side panel 436 and the cap rim 460, such thatthe gasket comprises the seal between the side panel 436 and the valvecap 452.

A rotating valve plate 472 may be rotatable between an open state and aclosed state relative to the valve cap 452. The valve plate 472 caninclude a bore 486 fluidly communicating with the holes 464 of the valvecap 452, which in turn fluidly communicates with the interior of thecontainer, when the valve plate 472 is in the open state. When thesensor module 570 is rotatably coupled to the container 430, the sensormodule 570 fluidly communicates with the bore 486 of the valve plate472. In this example, the valve plate 472 is rotatably disposed betweenthe inner surface of the side panel 436 and the adjacent inner face 454of the valve cap 452. The valve plate 472 can comprise a circular base474 and a rim 476 that extends circumferentially around the outerperimeter of the valve plate 472. A portion of the rim 476 extendsinwardly, toward the valve cap 452. The valve plate 472 may be coupledto the valve cap 452, such that the rim 476 of the valve plate 472 seatswithin and is able to rotate in the groove 456 that surrounds the innerface 454 of the valve cap 452. The rim 476 also projects a slightdistance in an outward direction from the face of the base 474 towardthe adjacent inner surface of the container side panel 436.

The base 474 of the valve plate 472 may comprise an outer face adjacentto the side panel 436 and a boss 484 that extends from this outer face.The boss 484 has a cross-sectional shape that is non-circular. In theillustrated example, the boss 484 is the shape of a polygon and, moreparticularly, a hexagon. The boss 484 is dimensioned to rotate inopening 438 formed in the adjacent side panel 436. Also extendingoutwardly from base 474 is a step 483, which is circular in shape andsurrounds the boss 484.

The valve plate 472 may comprise one or more channels 480 in fluidcommunication between the holes 464 of the valve cap 452 and the bore486 of the valve plate 472 when the valve plate 472 is rotated to theopen state. In particular, the valve plate 472 may comprise an innerface that is directed to the inner face 454 of the valve cap 452 and aplurality of channels 480. In the illustrated example, there are twochannels 480, which bisect one another and intersect at the center ofthe plate base 474. The valve plate 472 is further formed so that whenthe plate is in a particular rotational orientation relative to thevalve cap 452, each channel 480 is in registration with a separate oneof the holes 464 formed in the valve cap 452. The width across eachchannel 480 is no greater than the diameter of the holes 464.

The base 474 of the valve plate 472 may comprise the bore 486 extendingfrom the inner face of the base 474 and outwardly through the boss 484.As best shown in FIG. 25, the rim 476 further comprises a number ofarcuately spaced apart indentations 488 configured to receive acorresponding one of the ribs 458. Each indentation 488 extends inwardlyfrom the face of the rim 476 that is located adjacent the base of thecap groove 456. Each indentation 488 can be concave in shape andcomplementary to the profile of the ribs 458. The number of indentations488 can be equal to the number of cap ribs 458. The indentations 488 areangularly spaced apart from each other by the same angle about which theribs 458 are spaced apart from each other.

While the valve 450 has been described in detail above, otherconfigurations of the valve are contemplated so long as the valve isoperable to establish fluid communication between the sensor module andthe interior of the sterilization container when the sensor module iscoupled to sterilization container, and is also operable to maintainsterility of the sterilization container when the sensor module isdecoupled from the sterilization container.

In the illustrated embodiment, the valve plate 472 is configured torotate in one direction relative to the valve cap 452. In particular,the rim 476 of valve plate 472 has an additional set of indentations490, which extend radially inwardly from the outer circular surface ofthe rim 476. Some of the indentations 488 and indentations 490intersect.

When the valve 450 is mounted to the container body 432, in theillustrated embodiment, the valve plate 472 is disposed between theinner surface of side panel 436 and the valve cap 452. An O-ring 470 isseated in each of the grooves 466 internal to the valve cap 452. Boss484 extends through the opening 438 formed in the panel. The componentsforming the valve 450 are dimensioned so that the valve plate 472 canengage in limited longitudinal movement between the surface of sidepanel 436 and the valve cap 452. As seen in FIG. 24, a biasing member,such as wave washer 492 is disposed around the boss 484. The wave washer492 is compressed between the side panel 436 and the adjacent face ofthe valve plate base 474. The wave washer 492 presses the valve plate472 toward the static inner face 454 of the valve cap 452. Other typesof biasing members other than wave washer 492 may be used.

Referring to FIG. 23, a valve locking assembly 499 may be provided tolock the valve into the closed state when the sensor module is decoupledfrom the sterilization container. The valve locking assembly 499 isgenerally operable to block the rotation of the valve plate 472 in onedirection, and allow rotation in the opposite direction. The valvelocking assembly 499 prevents the HCP from inadvertently establishingcommunication between the interior of the sterilization container andexternal environment while the interior of the container is in thesterile state. More particularly, the valve locking assembly 499prevents the HCP from moving the valve plate to the open state from theoutside of the sterilization container when the sensor module isdecoupled from the sterilization container.

In one embodiment, the valve locking assembly 499 comprises pin 502,seen best in FIG. 23, slidably mounted in cap bore 468, along withspring 504 and a ferrule 506, which are disposed in the bore 468 and arepositioned to exert a force on the pin 502 in a direction toward thecenter of the valve plate 472, such that the tip of the pin 502 willseat in indentations 490 formed in the valve plate 472 to block therotation of the valve plate 472 in one direction and allow the rotationin the opposite direction. In this example, each indentation 490 caninclude a wall that extends perpendicularly to a tangent of the rim 476and radially inward from the rim 476 toward a valley, such that the pin502 is configured to contact this wall and prohibit rotation of thevalve plate 472 from the closed state to an open state. Furthermore,each indentation 490 can include an opposing wall or ramp portion thatextends radially inward from the rim 476 to permit the pin to slidealong the ramp and out of the indentation 490, such that the valve plate472 may be rotated from the open state to the closed state. A head 508may be disposed over the free end of the pin 502, the end of the pinthat projects outwardly of the valve cap 452. An individual can manuallyapply a force using his finger to overcome the force imposed by thespring 504, such that the pin can be withdrawn from the indentation 490in which the pin 502 is seated thus permitting the valve plate 472 torotate from the closed state to the open state. Put another way, the pin502 and indentations 490 can function together as a manually-operatedrotatable valve locking assembly that can selectively allow rotation ofthe valve 450 from the closed state to the open state when the container50 is opened and an individual accesses the valve locking assembly 499within the interior of the container. Other configurations of the valvelocking assembly are also contemplated, such a frictional or cammingengagement to prevent rotation of the valve plate in one direction uponengagement, i.e., after removal of the sensor module.

Referring to FIGS. 23, 26, and 27, the valve 450 may further comprise abezel plate 520 configured to sealingly contain electrical componentstherein and attach the sensor module 570 to the body 432. The bezelplate 520 is disposed over the outer surface of the side panel 436 towhich the valve 450 is mounted. The bezel plate 520 may include aring-shaped core 522, and two planar wings 530 extend outwardly from theopposed sides of the core 522. In the illustrated example, the core 522extends outwardly from the opposed top and bottom edges of the wings530. A rim 523 extends circumferentially outwardly around both the core522 and wings 530. The rim 523 also extends inwardly from the core 522and wings 530. When valve 450 is mounted to the container 432, the bezelplate 520 is positioned so the inner planar face of the rim 523 is theportion that abuts the side panel 436. The rim 523 thus holds both thecore 522 and wings 530 away from the adjacent surface of side panel 436.Thus, electrical components of the valve 450 can be sealingly containedwithin the wings 530 to protect those components from the effects of thesterilization process.

The bezel plate 520 is configured to removably couple the sensor module570 to the valve 450. More specifically, in this example, the core 522may define a center opening 524. The core 522 can further define twonotches 526, 528 (see FIG. 27). The notches 526, 528 are diametricallyopposed to each other relative to the center of opening 524. The notches526, 528 each open into the opening 524. The notches 526, 528 subtenddifferent arcs around opening 524. In the illustrated example, notch 526subtends a relatively small arc, and the notch 528 subtends a comparablylarger arc. The sensor module 570 comprises two tabs 596, 598 (see FIG.29) configured to be received in a corresponding one of the two notches526, 528, such that subsequent rotation of the sensor module 570attaches the sensor module 570 to the valve 450 and container 430.

In the illustrated example, the bezel plate 520 may comprise one or moreof the wings 530 including a hole 536, which is configured to receive anLED contained under the corresponding wing 530 and permit light to beemitted therethrough. The wings 530 can further comprise an icon 538 inthe shape of a lock, which is positioned on the wings 530 so as to alignwith an icon 577 (see FIG. 28) in the shape of an arrow formed on thesensor module 570 when the sensor module 570 is rotated to a positionthat removably attaches the sensor module 570 to the body 432.

As shown in FIGS. 28 and 30, the sensor module 570 may comprise a shell572 and a cap 580 mounted to the shell 572. The shell 572 may begenerally cylindrical in shape. The outer diameter of the shell 572 issuch that the shell 572 can be seated over and rotate over the core 522of the bezel plate 520. The shell 572 comprises at one end a base panel574 and is open at the opposing end. Two bosses 576, 578 projectoutwardly from the cylindrical sidewall of the shell 572. The boss 576is round in shape, and the boss 578 is rectangular in shape. Each boss576, 578 defines an opening into the shell 572.

As shown in FIG. 30, the module cap 580 comprises a circular base plate590. The base plate 590 is surrounded by a rim 582 that extendscircumferentially around the plate 590. The rim 582 extends outwardlyfrom the base plate 590 away from the surface of the plate that isdirected toward valve 450. The rim 582 comprises a groove 584 thatextends inwardly from the outer surface of the rim 582, and the groove584 extends circumferentially around the rim 582.

An O-ring 586 may be seated in groove 584 (see FIG. 32A). When thesensor module 570 is assembled, the cap rim 582 may be disposed adjacentthe inner surface of the cylindrical wall of the shell 572. The O-ring586 extends between the shell 572 and the cap 580 to provide a sealbetween these two components. Other configurations of the sensor moduleare also contemplated so long as the sensor module is able to sealinglyenclose the electronic components and sensors so as to protect them fromthe sterilant agents while also permitting the sensors to measure thecharacteristics of the sterilant agent(s) and/or the interior of thecontainer 50.

A pedestal 592 (see FIG. 29), also part of cap 580, extends outwardlyfrom base plate 590 and toward the valve 450. Pedestal 592 may becircular in shape. The pedestal has a diameter that allows the pedestalto seat in and rotate in the center opening 524 internal to the bezelplate core 522. Forward of the pedestal 592, cap 580 has a circular faceplate 594, which has a diameter slightly less than that of the pedestal592. Two diametrically opposed tabs 596 and 598 are integral with andextend radially outwardly from the face plate 594. The tabs 596 and 598subtend different arcs. Tab 596 is dimensioned to seat in notch 526internal to the bezel plate 520. Tab 598 subtends an arc that does notallow the tab 598 to seat in notch 526 but will allow the tab 598 toseat in notch 528. Tabs 596, 598 and notches 526, 528 arranged asdescribed provide a single orientation to the sensor module 570 whenmounted to the body 432, such that one or more components of the sensormodule 570 can be disposed in a specific configuration to perform theircorresponding functions. In one example, as will be described below, thesensor module 570 includes a drain plug 623 (FIG. 32A), which isdisposed at a lowermost location of the sensor module 570 when thesensor module 570 is mounted to the body 342, such that condensatewithin the sensor module 570 can flow away from sensors and othercomponents toward the drain plug 623. However, the sensor module 570 canhave other orientations when mounted to the body 432 and othercomponents that perform corresponding functions based on the orientationof the sensor module.

Cap 580 is further formed so as to have an opening 602 in the center ofthe face plate 594. Opening 602 is non-circular in shape. Moreparticularly, sleeve 604 has a shape that complements the shape of boss484 that is integral with the valve plate 472. Opening 602 opens intothe center void of the sleeve 604 formed integrally with cap 580. Thesleeve 604 extends inwardly from the face plate 594. The components arearranged so that when the sensor module 570 is fitted to the containerbody 432, the boss 484 operatively snap-fits into opening 602 and seatsin the sleeve 604.

While the specific exemplary embodiment as described above is directedto a configuration including the bezel plate removable coupling thesensor module 570 to the valve 450, it is contemplated that variousother suitable devices and arrangements may be utilized to removablycouple the sensor module 570 to the valve 450.

An O-ring 595 may be mounted to the cap face plate 594. The O-ring 595is mounted in a groove that is spaced radially outwardly from andextends circumferentially around opening 602, (groove not identified).The O-ring 595 thus extends forward of plate 594 and extends aroundopening 602.

Referring to FIGS. 30-32A, a block 608 may be mounted to the inner faceof the cap base plate 590. The block 608 is often formed from metal or ahigh temperature resistant thermoplastic able to repeatedly withstandthe sterilization process conditions. The block 608, as seen in FIG. 31,is formed with a number of bores and voids. A bore 612 extends inwardlyfrom the face of the block 608 located adjacent the cap 580. Acounterbore 613 identified, extends around the section of bore 612adjacent the cap 580. Counterbore 613 is positioned to receive sleeve604 so that opening 602 opens into bore 612. In the illustrated example,bore 612 extends to the face of the block 608 spaced furthest from thecap 580. A raised boss 609 surrounds the open end of bore 612. Theinterior wall of block 608 that defines the section of bore 612 locatedinward of boss 609 may be threaded (threading not illustrated). Thethreading facilitates the engagement of a fastener 630, identified inFIG. 32A, in this section of bore 612. The fastener 630, which extendsthrough the opening and counterbore 575 of the shell base panel 574,holds the shell to the block 608 and by extension, the cap 580. Notillustrated are the fasteners or other components that hold the block608 to the cap.

A bore 614 intersects and extends perpendicularly to bore 612. Bore 614is formed to have sections with different diameters, individual sectionsnot identified. Two elongated voids 616 extend inwardly from the backface of block 608, the face of the block spaced furthest from cap 580.Each void 616 is centered on a longitudinal axis that is parallel to thelongitudinal axis through bore 612. Each void 616 intersects bore 614.Each void 616 is formed with sections that have different diameters,individual sections not identified. The larger diameter sections of eachvoid 616 are located adjacent the face of the block 608 spaced furthestfrom the cap 580.

Two additional voids, voids 618, one identified in FIG. 30, are alsoformed in the block. Voids 618 have longitudinal axes that are parallelto the longitudinal axis through bore 612. Each void 618 extendsinwardly from the end of the block adjacent the shell base panel 574.

As mentioned above, the sensor module may include one or more sensors.In one potential implementation, the sensors are mounted to block 608 asseen in FIG. 32A. In the illustrated example, two temperature sensors620 are mounted to the block 608. In the illustrated example, thetemperature sensors 620 are substantially identical to the previouslydescribed temperature sensor 240 described with respect to FIGS. 5 and8. Each temperature sensor 620 is mounted to the block so the elongatedtube of the sensor 620 is fitted in the small diameter portion of one ofthe bores 614. Two pressure sensors 628 are also illustrated in FIGS. 30and 32B. Pressure sensors 628 could measure gage pressure or absolutepressure, the latter being beneficial when using the measurement toaccurately evaluate the steam saturation state. Pressure sensors 628 andtemperature sensors 620 may be arranged so that condensate flows awayfrom the same due to gravity so the sensors 620, 628 provide a moreaccurate reading that is not influenced by the amount of condensate onany corresponding one of pressure sensors 628 and temperature sensors620. However, it is contemplated that the sensor module 570 can containany one or more gas concentration sensors described above, such as theoptical sensor assemblies 202, 202′, 202″, 202′″, as described above, orany other sensor configured to measure characteristics within thecontainer during the sterilization process, such as those describedbelow.

Referring to FIGS. 30 and 32A, in one embodiment, the plug 622 isdisposed within one of the open ends of bore 614 and is contained withinthe shell 572. The plug 622 is made from a metal to create a thermalmass and is configured to contain a temperature sensor (not shown). Asshown in FIG. 32A, the plug 622 comprises a bore having an opening thatfaces the inner surface of the shell 572, and the bore is configured toreceive the temperature sensor. The temperature sensor is configured tomeasure the rate of change of the temperature of the mass in order todetermine the state of steam saturation of the sterilization process.

The opposite end of plug 622 may be sealed to stepped bore 614 and has asurface area for heat transfer from steam and gasses present in bores612, 614, which are fluidly coupled to the inside of container duringthe sterilization process. A second plug 623 may be mounted to theopposite end of bore 614. The plug 623 is mounted to the sensor module570 to project out of the boss 576. A plug 623 is configured to permitcondensate to pass there through and be discharged from the sensormodule 570. The plug 623 is formed to define a void 621 that is open tothe bore 614. A float ball 626 is seated in the void 621. There is asmall gap between the outer surface of ball 626 and the inner surface ofthe block 608 that defines the void 621, such condensate can flow aroundthe ball as the ball floats upward along the void 621 axis andcondensate flows out of the plug 622. A bore 627 extends from the baseof the void 621 to the outer face of plug 623. Bore 627 has a diameterless than that of the ball. The float ball 626 is configured in anormally closed state due to gravity, such that air and gasses presentin void 621 do not escape past the float ball 626. Float ball 626functions to allow liquid condensate to lift the float ball 626 andallow condensate liquid to drain through bore 627. Alternativemechanisms to control condensate outflow from the sensor module may alsobe used.

In an alternate example, the thermal mass plug 622 can be locatedadjacent and above the condensate drain plug 623, below the lower sensor620 with a surface area for heat transfer exposed within the steppedbore 614 between float valve drain plug 623 and sensor 620. In thisexample, the heat transfer rate to the thermal mass plug 622, asmeasured by the temperature sensor attached to the thermal mass, couldaid in determining if there is a mixture of air or other gases with thesteam sterilant present in the fluidly connected bores 612, 614 duringthe sterilization process. This alternate location could be advantageousin determining a more accurate steam saturation state of the sterilantpresent in the interior of the container 430 during the sterilizationprocess.

A circuit board 629 may be also mounted to the block 608. Mounted to thecircuit board are the below discussed components that control theoperation of the sensor module 570 and that respond to the signalsoutput by the temperature sensors 620, including the processor. Cells631 may be disposed in the block 608 as seen in FIG. 30. In theillustrated example, two cells 631 are disposed in each void 618. Thecells 631 provide the charge needed to power the electrically-actuatedcomponents internal to the sensor module 570. Cells 631 can includeinsulation, a phase change material, such as paraffin, urea, or otherprotective materials, so as to regulate heat transfer during thesterilization process and thus prevent overheating the cells 631 whilethey are operating within the container 430.

A terminal 632 is mounted to the boss 578 integral with the module shell572. Terminal 632 performs the same function as the previously discussedterminal 132.

Referring to FIG. 32A, a number of O-rings are seen mounted in groovesformed in block 608. The majority of the O-rings and grooves are notidentified. It is understood that these O-rings function as sealsbetween the block 608 and the components mounted to the block 608against which the O-rings are disposed. One O-ring that is identified isO-ring 634. The O-ring 634 sits in the step between counterbore 613 andbore 612. These O-rings create seals preventing sterilant gases fromentering the cavities containing the electrical components of the sensormodule 570.

FIG. 33 is a block diagram of the electrical components mounted to boththe valve 450 and the sensor module 570. The electrical componentsinternal to the valve 450 are contained in a shell disposed below one ofthe wings 530 of the bezel plate 520 (shell not illustrated). It isunderstood that the shell is able to shield the components from theeffects of the sterilization process to which container 430 is exposed.

One of the illustrated components is a communication device, shown as anantenna 542. Antenna 542 is able to broadcast signals to and receivesignals from complementary antenna external from the valve 450. Antenna542 is connected to a transmitter/receiver 544. The transmitter/receiver544 converts received signals into digital signals. Transmitter/receiver544 also formats digital signals into a form in which the signals can bebroadcast by the antenna 542. A processor 546 is also mounted to thevalve 450. Processor 546 receives the data signals from thetransmitter/receiver 544 and transmits data to the transmitter/receiver.Not identified is the memory internal to the processor 546. Of course,other communication devices other than antennas may also be used tocommunicate from the processor 546, and the communication device mayutilize any suitable communication protocol, such as RF, near-field,Bluetooth, cellular or Wi-Fi communication.

Another component that may optionally be connected to processor 546 is alid sensor 545. Sensor 545 does not necessarily have to be disposed inthe same shell in which the processor 546 is disposed. Sensor 545monitors whether or not the lid 440 is attached to the body 432. In someexamples, sensor 545 is a sensor sensitive to magnetic fields. One suchsensor is a Hall Effect sensor. In these versions, a magnet (notillustrated) may be mounted to the lid 440. The magnet is mounted to thelid 440 so that when the lid 440 is mounted to the body 432 the magnetis in close proximity to sensor 545. Other types of lid sensors are alsocontemplated.

In the illustrated example described above, the notification deviceconfigured to communicate information to the HCP indicative of thesterilization state of the container 430 is an LED 548, i.e., whetheracceptable sterilant agent(s) or sterilization process conditions havebeen achieved within the container. In some examples, the LED 548 iscapable of emitting different colors of light and/or intermittentlyflash on and off depending on the sterilization state of the container.The LED 548 is mounted to the valve so the light emitted by the LED 548is visible through the hole 536 in the bezel plate 520. A cell 550, onlyshown connected to the processor 546 also mounted to the valve, providesthe power used to actuate the electrically actuated components of thevalve 450. It is contemplated that the notification device can compriseany one or more of the notification devices described herein, or anyother device configured to communicate the sterilization state of thecontainer.

The sensor module 570 comprises a processor 650. The output signalsgenerated by the sensors disposed therewith, such as temperature sensors620, are applied to the processor 650. Processor 650 performs the samegeneral functions as processor 384. Terminal 632 is also connected tothe processor 650. It is contemplated the processor 650 can beconfigured to perform the same functions as the processor 546 to sendsignals to the same notification devices coupled to the valve 450 orsimilar notification devices coupled to other portions of the container430 or otherwise used to communicate the sterilization state of thecontainer 430.

Also shown internal to the sensor module can be a transmitter/receiver652 and an antenna 654. The transmitter/receiver 652 responds to dataand commands output by the processor by broadcasting appropriate signalsover the antenna 654. Transmitter/receiver 652 receives from the antenna654 the signals received over the antenna. The transmitter/receiverconverts the received signals into a form in which the signals can beprocessed by processor 650. It should thus be appreciated thatprocessors 546 and 650 are able to communicate wirelessly over antennae542 and 654. Of course, other communication devices other than antennasmay also be used to communicate from the processor 546, and thecommunication device may utilize any suitable communication protocol,such as RF, near-field, Bluetooth, cellular or Wi-Fi communication.

Terminal 632 is shown connected to the processor 650. Cells 631 areshown connected to the processor. This connection represents that thecells 631 power the charge-consuming components internal to the sensormodule 570 and cells can be optionally re-charged through terminal 632.

Referring to FIGS. 34A-34C, when the sterilization container 430 isinitially prepared for use, the sensor module 570 is typically notattached to the container 430 and the valve 450 is in the closed andlocked state. When the valve 450 is in the closed state, the valve plate472 is typically in a rotational orientation relative to the valve cap452, so that each of the indentations 488 associated with the valveplate 472 is disposed over one of the ribs 458 associated with the cap452. As a result of the biasing force imposed by the wave washer 492 orother biasing device, the valve plate 472 is urged toward the valve cap452 so that each rib 458 seats in the adjacent indentation 488 as seenin FIG. 34A. When the valve plate 472 is in this orientation, the platechannels 480 are not in registration with the holes 464. The base 474 ofthe valve plate 472 presses against the O-rings 470, which are locatedaround the holes 464 of the valve cap 452 as seen in FIG. 34B. TheO-rings 470 thus form seals between the valve cap 452 and valve plate472, thus preventing the holes 464 of the valve cap 452 from fluidlycommunicating with the channels 480 and the bore 486 of the valve plate472. The valve 450 is thus in a closed state. Other sealing membersother than the aforementioned O-rings are also contemplated inalternative constructions.

Referring to FIGS. 35A-35C, the valve plate 472 provides clearancearound the O-rings 470, or other sealing members, when the valve 450 isin the open state, such that a substantial portion of the O-rings 470that interface with the valve 450 are exposed to the penetratingsterilant gases for sterilizing the O-rings, and the O-rings 470 canalso wipe sterilant agent(s) onto a surface of the valve plate 472 whenthe valve 450 is moved from the open state to the closed state. Putanother way, a significant portion of valve seal surfaces are exposed tosterilant gas by translating the valve plate 472 away from the valve cap432. Rotating alone could allow contaminants residing outside the sealcontact area during sterilization to survive the sterilization process,and the surviving contaminant could be smeared between the sealingsurfaces during only rotational closing of the valve plate thuspotentially contaminating the container interior surfaces, which maycompromise the sterility of the instruments included in the interior ofthe container. However, with reference to FIG. 25, it is contemplatedthat other examples of the valve plate 472 may not be configured toprovide a clearance for the O-rings 470 to expose a larger portion ofthem to the sterilant chemicals.

In one embodiment, when the valve 450 is in the closed state, the pin502 is received in one of the indentations 490 in the valve plate 472.The presence of the pin 502 in one of the indentations 490 blocks therotation of the valve plate 472 from the closed state to the open state.One or more instruments 60 are then placed in the interior of thecontainer body 432.

The sensor module 570 is mounted to the valve 450, with the sensormodule being a drive element moving between two positions and the valve450 being a driven element movable between the closed and open states inresponse to the sensor module being moved between the two positions. Inthis example, the sensor module 570 is mounted to the valve 450 so as totransfer torque from the sensor module 570 to the valve 450, such thatthe sensor module 570 and the valve plate 472 rotate in synchronizationwith one another.

Referring to FIGS. 23, 26 and 29, the sensor module 570 is aligned in arotational position with respect to the bezel plate 520, such that thetabs 596, 598 (FIG. 29) are received through a corresponding one of thenotches 526, 528 (FIG. 26) of the bezel plate 520, and the hexagonalboss 484 (See FIG. 23) of the valve plate 472 is received in thehexagonal bore 604 (See FIG. 29) of the sensor module 570. However, itis contemplated that the bore of the sensor module and the boss of thevalve plate can have other suitable non-circular male and femaleconnector configurations to permit the sensor module 570 to drive orrotate the valve 450. As but one example, the boss of the valve platecan have splines that mesh with corresponding grooves formed within aninner diameter surface of the sleeve of the valve plate. As still afurther example, the boss of the valve plate can have a keyway thatmeshes with corresponding a key seat formed in the sleeve of the valveplate.

Once the sensor module 570 is rotatably mounted to the valve 450, thevalve 450 can be moved from the closed state to the open state only whenthe valve locking assembly 499 is accessed from within the interior ofthe container 430 to disengage the valve plate 472 from a stationarycontainer structure, such as the valve cap 452. In one example, thecontainer 430 includes the lid 440 and the body 432, and the valvelocking assembly 499 can be accessed only when the lid 440 has beenremoved from the body 432. Thus, the valve locking assembly 499, onceengaged, may not be accessed until the sterility of the container hasalready been compromised.

More specifically, in this example, the valve locking assembly 499 maybe operated by applying an upward force to the head 508 of pin 502,which in turn retracts the pin 502 from the indentation 490 in which thepin 502 is seated. This movement of the pin 502 away from the valveplate 472 allows the valve plate 472 to rotate from the closed state tothe open state by rotating the sensor module 570 from its first positionto its second position. Of course, other configurations of the valvelocking assembly are contemplated other than pin mechanism describedabove.

The sensor module 570 is rotated from the closed state to the openstate. In this example, this movement is made in the counterclockwisedirection as viewed from the perspective of the interior of thecontainer or in the clockwise direction as viewed from the perspectiveexternal to the container, until the module icon 577 aligns with thevalve icon 538 on the bezel plate 520 and the valve 450 is positioned inthe open state. At least one optional rotation stop 579 (one shown inFIG. 26) can extend from the plate core 522 toward the containerexterior panel and positioned to engage tabs 596 and/or 598 to provide aphysical rotation stop when module icon 577 aligns with valve icon 538and the valve 450 is positioned in the open state. When the sensormodule 570 is in this rotational orientation relative to the bezel plate520, tabs 596 and 598 are disposed under the plate core 522. Thispositioning of the tabs 596 and 598 relative to the bezel plate 520serves to releasably hold the sensor module to container 430.

In the described version, when the sensor module 570 is so aligned tothe container, plug 623 is, by reference to the gravity plane, locatedat the bottom of block 608. This configuration positions the float ball626 to allow liquid to drain from plug 623 as described earlier.

As a result of the rotation of the valve plate 472, the sections of thevalve plate 472 that define indentations 488 rotate away from the ribs458, and the valve plate 472 is displaced away from the adjacent innerface of the valve cap 452. This longitudinal displacement of the valveplate 472 is in opposition to a force placed on the valve plate 472 bythe wave washer 492. The wave washer 492 is selected so all that isrequired to overcome the force of the washer is the manual force neededto rotate the valve plate 472. As a result of the displacement of thevalve plate 472, the valve plate 472 rotates to an orientation in whicheach one of the cap holes 464 is in registration with one of thechannels 480, and the O-ring 470 is not in contact with base 474. Afluid communication path thus exists from the void internal to thecontainer body 432 through the holes 464, the channels 480, and bore 486into the sensor module bore 612. The valve 450 is thus in the openstate.

As a result of the sensor module 570 being locked to the valve 450,O-ring 595 is compressed between the valve plate 472 and the module cap580. The O-ring 595 thus forms a barrier that surrounds the fluidcommunication path between the void internal to the container body 432and the sensor module bore 612.

Also, once the sensor module 570 is mounted to the sterilizationcontainer the processor 546 may provide data to the processor 650, asillustrated in FIG. 33. These data describe the sterilization processconditions within the container 430.

Assuming a filter medium 410 is mounted to the lid 440, the lid issealed over the open end of the body 432 of the container 430. Once thecontainer 430 is in this state, the container 430 is ready to be placedin the sterilizer device.

Container 430 and the contents are subjected to the same sterilizationprocess to which a conventional container is subjected.

During the sterilization process the sterilant gases and vapors thatflow into the container void space flow through the valve 450 into thebores 612 and 614 internal to the sterilization module 570. The sensorswithin the sensor module, such as temperature sensors 620, are thereforeable to measure the characteristics of the environment internal to thecontainer 430.

In the illustrated example, container 430 is designed to holdinstruments that are subjected to steam sterilization or othersterilization gas. The water vapor (steam) in the bores 612 and 614 maycondense. This water will, owing to gravity, flow toward plug 623. Thewater will cause ball 626 to float. As a result of the ball floating, asizable fraction of the water will flow out of the plug 623 through bore627.

Referring to FIGS. 30 and 32A, based on the signals from the varioussensors mounted within the sensor module 570, the processor 650,determines whether or not the instruments have been subjected tothreshold process conditions that ensure a desired level ofsterilization. As one example, the processor 650 can compare themeasured characteristics from the sensors to data in a lookup table forthreshold process conditions that ensure a desired level ofsterilization. As shown in FIG. 33, the processor 650 informs theprocessor 546 of the results of this evaluation. If the evaluation ispositive, the processor 546 actuates the notification device tocommunicate the status of the container 430 and instruments as beingdecontaminated to the desired level of sterilization. In this example,notification device comprises the LED 548, and the processor 546actuates the LED 548 to emit a first color of light. If the evaluationis negative, the processor 546 actuates the LED 548 to emit a secondcolor of light. The color light that is seen from the LED 548 thusprovides an indication regarding whether or not the instruments 60 inthe container have been subjected to threshold process conditions thatwould ensure a desired level of sterilization.

Once sterilization process has been completed and it is determined thatthe instruments have been exposed to threshold process conditions thatensure that the desired level of sterilization has been achieved, thesensor module 570 can be removed from the container 430, and the valvelocking assembly 499 can prevent a contaminated sensor module from beingattached to the container 430 and fluidly communicating with theinterior of the container and the sterilized instruments therein. Thisstep may be performed by first rotating the sensor module 570counterclockwise from its second position to its first position, whichin turn rotates the valve plate 472 counterclockwise from the open stateto the closed state, such that the tabs 596, 598 (FIG. 29) of the sensormodule 570 are aligned with the notches 526, 528 (FIG. 27) of the bezelplate 520 and the sensor module 570 can be removed from the valve plate.Of particular interest, because the valve plate 472 has been returned tothe closed state, the indentation 490 is aligned with the bore 468 ofthe valve cap 452, such that the valve locking assembly 499 is actuated.In this example, the spring 504 moves a portion of the pin 502 into theindentation 490 and the valve locking assembly 499 engages the valveplate 472 to prevent the valve plate 472 from being rotated from theclosed state to the open state, which is movement in a counterclockwisedirection from the perspective within the interior of the container orin a clockwise direction from the perspective external to the container.In this respect, after the sensor module 570 has been removed from thevalve 450, a contaminated sensor module may be mounted to the valve 450,but the valve locking assembly 499 prevents the valve plate 472 frombeing moved from the closed state to the open state, which in turnprevents the contaminated sensor module from fluidly communicating withthe interior of the container and the sterilized surgical instrumentscontained therein. Again, as described above, the valve locking assembly499 is accessible only from within the interior of the container 430 todisengage the valve locking assembly 499 from the valve plate 472 andpermit the valve plate 472 to rotate from the closed state to the openstate when the lid 440 is removed from the body 432.

More particularly, the valve plate 472 rotates so the indentations 488are again placed in registration with the ribs 458. The wave washer 492releases the potential energy stored in the washer. This potentialenergy pushes the plate base 474 back against the O-rings 470. The valve450 is thus back in the closed state. Only when the valve 450 is sopositioned are tabs 596 and 598 in registration with, respectively, thebezel plate notches 526 and 528. Only when the tabs 596 and 598 are inthis rotational orientation is it possible to remove the sensor module570 from the container 430. Thus, this version is constructed so thatonly after the valve 450 returns to the closed state is it possible toremove the sensor module 570 from the container 430.

After the sensor module 570 is removed from the sterilization container430, the processor 546 continues to actuate the notification device tocommunicate the status of the container 430 and/or instruments therein.Continuing with the previous example, the notification device is the LED548 configured to emit light indicating that the desired level ofsterilization has been achieved for the instruments 60 in the container430. Thus, the HCP wanting access to a set of instruments 60 that havebeen sterilized does not have to look for a container with sensor moduleattached. The HCP only needs to look for a container 430 with anotification device that is activated, such as LED 548 that is emittinglight to indicate that the desired level of sterilization has beenachieved for the instruments 60 in the container.

Also as a result of the rotation of the valve plate 472 back to theclosed state, one of the indentations is rotated back into registrationwith pin 502. Spring 504 pushes the pin 502 back into the indentation490. Thus the valve 450 returns to the locked state. This eliminates thelikelihood that contact with the exposed sections of valve plate 472 andboss 484 could result in the inadvertent opening of the valve 450.

When it is time to use the instruments 60 in the container 430, the lid440 is removed. Sensor 545 asserts a signal to the processor 546indicating that the lid has been removed. In response to receipt of thissignal, the processor 546 resets the notification device, such as LED548 so the LED no longer asserts a signal indicating that theinstruments in the container are sterile due to this breach in thesterile barrier formed by the container system.

A benefit of this version is that once a first sterilization container430 and its contents have been sterilized, the sensor module 570 can beremoved without contaminating the interior of the container. Byexamining the notification device, the HCP can determine thesterilization state of the container 430. Still continuing with theprevious example, the notification device comprises the LED 548, and theHCP observes the light emitted from the LED 548 associated with thefirst container to indicate that the desired level of sterilization hasbeen achieved for the instruments in the container 430. The sensormodule 570 can then be attached to a second sterilization container thathas not yet been subjected to the sterilization process, such that thesensor module 570 can be used to determine whether the desired level ofsterilization has been achieved for instruments within the secondsterilization container. This eliminates the need to provide eachsterilization container with its own sensor module 570. In other words,the sterilization containers can be stored with their contents remainingin a sterilized state, with the sensor module being removed therefore.

FIGS. 36A-36E and 37 illustrate an alternative valve 450 a that can beattached to a sterilization container 430. The valve 450 a issubstantially identical to the valve 450 shown in FIGS. 23-25. The mostsignificant difference between the two valves is that valve 450 a isconfigured to releasably hold a filter 676.

The valve 450 a includes a valve cap 452 a substantially identical tothe valve cap 452 shown in FIGS. 23-25. The valve cap 452 a is formed tohave a rim 460 a, which is similar to rim 460 because it extendsoutwardly from the inner face 454 a of the valve cap 452 a. Rim 460 aalso extends outwardly from the outer face 454 b of the valve cap 452 a,the face of the plate directed to the void space internal to thecontainer body 432. The valve cap 452 a also contains a post 672, whichextends outwardly from the outer face of the valve cap 452 a. This post672 extends outwardly from the center of the valve cap 452 a, and thepost 672 is similar in structure and function to the post 82 of FIGS.10A and 10E.

The filter 676 is shaped to seat over the outer face of the valve cap452 a and within the rim 460 a. The filter 676 is formed with an opening(not identified) for receiving post 672. A filter frame 680 similar infunction, though smaller in size than filter frame 320, is disposed overthe outwardly directed surface of the filter. Filter frame 680 isdimensioned to seat within rim 460 a and seat against filter 676. Thefilter frame 680 is releasably secured to post 672.

It should be understood that the version described by reference to FIGS.36A and 37 is primarily for use when the presence of filter 676 will notappreciably affect the ability of the sensors internal to module 570 tomeasure characteristics within the container 430. For example, theconcentration of a sterilant gas may be reduced as the sterilant gasflows through the filter 676. If an accurate measurement of theconcentration of this sterilant gas inside the container 430 isrequired, the container should include the first described valve 450 ofFIG. 23. This is because this valve 450 does not, when open, provide anybarriers to the flow of the sterilant gas from the container void spaceto the module sensors.

FIGS. 36A-36E and 37 further illustrate an alternative valve lockingassembly 499 a, which is similar to the valve locking assembly 499 ofFIG. 23 and includes similar components identified by the same referencenumbers followed by the suffix “a”. While the valve locking assembly 499of FIG. 23 is generally operable to block the rotation of the valveplate 472 in one direction and allow rotation in the opposite direction,the valve locking assembly 499 a is generally operable to block therotation of the valve plate 472 a in both the clockwise direction andthe counterclockwise direction. More specifically, while the valve plate472 of FIG. 23 has eight indentations 490 and each indentation 490includes a wall or ramp portion that permits the pin 502 to slide alongthe ramp and out of the indentation 490, the valve plate 472 a includesfour bores 490 a and none of the bores 490 a include the ramp. Rather,each bore 490 a includes opposing walls that extend radially inward andperpendicularly from a tangent of the rim 476 a of the valve plate 472a, such that the pin 502 is configured to contact the walls and prohibitrotation of the valve plate 472 a in any direction.

Referring to FIGS. 36B and 36C, once the sensor module 570 is mounted tothe valve 450 a, the valve 450 a can be moved from the closed state tothe open state only when the valve locking assembly 499 a is accessedfrom within the interior of the container 430 to disengage the valveplate 472 a from a stationary container structure, such as the valve cap452 a. In one example, the container 430 includes the lid 440 and thebody 432, and the valve locking assembly 499 a can be accessed only whenthe lid 440 has been removed from the body 432. Thus, the valve lockingassembly 499 a, once engaged, may not be accessed until the sterility ofthe container has already been compromised.

More specifically, as shown in FIG. 36B, the exemplary valve lockingassembly 499 a may be operated by applying an upward force to the head508 a of pin 502 a, which in turn retracts the pin 502 a from the bore490 a in which the pin 502 a is seated. This movement of the pin 502 aaway from the valve plate 472 a allows the valve plate 472 a to rotatefrom the closed state to the open state (as shown in FIG. 36C) byrotating the sensor module 570 from its first position to its secondposition. Of course, other configurations of the valve locking assemblyare contemplated other than pin mechanism described above.

Referring to FIG. 36C, the sensor module 570 has been rotated from theclosed state to the open state by virtue of manually pulling the pin 502a out of the bore 490 a and subsequently rotating the sensor module 570from its first position to its second position. Once so rotated, the pin502 a is released and thereafter allowed to rest on an outer peripheralsurface of the valve plate 472 until the valve plate 472 a is moved backto the closed state as described further below, at which time the pin502 a rides along the outer peripheral surface until becoming againaligned with the bore 490 a and accordingly biased back into the bore490 a to prevent both clockwise and counterclockwise movement. In thisexample, this movement is made in the counterclockwise direction asviewed from the perspective of the interior of the container or in theclockwise direction as viewed from the perspective external to thecontainer, until the module icon 577 aligns with the valve icon 538 onthe bezel plate 520 and the valve 450 a is positioned in the open state.At least one optional rotation stop 579 (one shown in FIG. 26) canextend from the plate core 522 toward the container exterior panel andpositioned to engage tabs 596 and/or 598 to provide a physical rotationstop when module icon 577 aligns with valve icon 538 and the valve 450 ais positioned in the open state. When the sensor module 570 is in thisrotational orientation relative to the bezel plate 520, tabs 596 and 598are disposed under the plate core 522. This positioning of the tabs 596and 598 relative to the bezel plate 520 serves to releasably hold thesensor module 570 to container 430.

Referring to FIGS. 36D and 36E, once the sterilization process has beencompleted and it is determined that the instruments have been exposed tothreshold process conditions that ensure that the desired level ofsterilization has been achieved, the sensor module 570 can be removedfrom the container 430, and the valve locking assembly 499 a can preventa contaminated sensor module from being attached to the container 430and fluidly communicating with the interior of the container and thesterilized instruments therein. This step is performed by first rotatingthe sensor module 570 counterclockwise from its second position to itsfirst position, which in turn rotates the valve plate 472 acounterclockwise from the open state to the closed state, such that thetabs 596, 598 (FIG. 29) of the sensor module 570 are aligned with thenotches 526, 528 (FIG. 27) of the bezel plate 520 and the sensor module570 can be removed from the valve plate. Of particular interest, becausethe valve plate 472 a has been returned to the closed state, the bore490 a of the valve plate 472 a is aligned with the bore 468 a of thevalve cap 432, such that the pin 502 a is received in both of the bores490 a, 468 a in the locked position. In this example, the spring 504 amoves a portion of the pin 502 a into the bore 490 a and the valvelocking assembly 499 a engages the valve plate 472 a to prevent thevalve plate 472 a from being rotated in any direction. In this respect,after the sensor module 570 has been removed from the valve 450 a, acontaminated sensor module may be mounted to the valve 450 a, but thevalve locking assembly 499 a prevents the valve plate 472 a from beingmoved from the closed state to the open state, which in turn preventsthe contaminated sensor module from fluidly communicating with theinterior of the container and the sterilized surgical instrumentscontained therein. Again, as described above, the valve locking assembly499 a is accessible only from within the interior of the container 430to disengage the valve locking assembly 499 a from the valve plate 472 aand permit the valve plate 472 a to rotate from the closed state to theopen state when the lid 440 is removed from the body 432.

More particularly, the valve plate 472 a rotates so the indentations 488are again placed in registration with the ribs 458. The wave washer 492releases the potential energy stored in the washer. This potentialenergy pushes the plate base 474 back against the O-rings 470. The valve450 a is thus back in the closed state. Only when the valve 450 a is sopositioned are tabs 596 and 598 in registration with, respectively, thebezel plate notches 526 and 528. Only when the tabs 596 and 598 are inthis rotational orientation is it possible to remove the sensor module570 from the container 430. Thus, this version is constructed so thatonly after the valve 450 a returns to the closed state is it possible toremove the sensor module 570 from the container 430.

After the sensor module 570 is removed from the sterilization container430, the processor 546 continues to actuate the notification device tocommunicate the status of the container 430 and/or instruments therein.Continuing with the previous example, the notification device is the LED548 configured to emit light indicating that the desired level ofsterilization has been achieved for the instruments 60 in the container430. Thus, the HCP wanting access to a set of instruments 60 that havebeen sterilized does not have to look for a container with sensor moduleattached. The HCP only needs to look for a container 430 with anotification device that is activated, such as LED 548 that is emittinglight to indicate that the desired level of sterilization has beenachieved for the instruments 60 in the container.

When it is time to use the instruments 60 in the container 430, the lid440 is removed. Sensor 545 asserts a signal to the processor 546indicating that the lid has been removed. In response to receipt of thissignal, the processor 546 resets the notification device, such as LED548 so the LED no longer asserts a signal indicating that theinstruments in the container are sterile due to this breach in thesterile barrier formed by the container system.

While the exemplary sensor modules described above are configured tomeasure characteristics within the interior of the container during asterilization process, based on the concentrations of sterilant gases,temperature, and pressure within the container, another exemplary sensormodule can determine whether the desired level of sterilization has beenachieved based on a calculated steam saturation state in view of thetemperature measurements of one or more thermal masses, the pressuremeasurements during the sterilization process, the length of thesterilization process, and/or any combination thereof. It iscontemplated that one or more sensor modules can be used to determinesterilization process conditions within a container based on anycombination of the concentrations of sterilant gases, temperaturemeasurements, pressure measurements, the temperature measurements of oneor more thermal masses, the pressure measurements during thesterilization process, and/or the length of the sterilization process.

One exemplary sensor module can be configured to measure characteristicswithin the interior of the container during a sterilization process anddetermine the steam saturation state based on the temperature of one ormore thermal masses, the pressure during the sterilization process, thelength of the sterilization process, and any combination thereof.

Pressures higher than atmospheric pressure are necessary to increase thetemperature of the steam for destruction of micro-organisms that can bemore difficult to kill. The saturated steam at a required temperatureand time must penetrate and reach every surface of the items to besterilized. When steam initially enters the container at a predeterminedpressure, the steam condenses upon contact with comparably colder items,including the instruments within the container and internal surfaces ofthe container. This condensation releases heat, simultaneously heatingand wetting surfaces exposed to the interior of the container. Theinstruments must be exposed to moist heat for a minimum time and at aminimum defined temperature in order to provide proper sterilization.For example, one type of instrument may require exposure to 100%saturated steam for 4 minutes at 270 degrees Fahrenheit to destroy themicro-organisms and another 20 minutes of evacuation to dry theinstrument within the container so that condensation does not accumulatewithin the container. A minimum temperature-time and steam concentrationrelationship is required to be maintained as the threshold processconditions throughout all portions within the container and throughoutthe container to properly kill target micro-organisms and ensure thatthe desired level of sterilization has been achieved. The time,temperature, and steam concentration to destroy micro-organisms dependupon many characteristics measured within the container. For example,the size, surface area, thermal mass, orientations, and depths ofinternal cavities of the contents within the container as well as thesteam penetration properties of the container can affect the efficiencyof destroying micro-organisms. Ideal steam for sterilization is 100%saturated steam. Saturated steam (100% relative humidity) has a highheat content, and no water in the form of a fine mist is present withinthe saturated steam. The steam saturation state can be determined basedon the rate of change in temperature of a known mass.

FIG. 38A depicts another exemplary sensor module 692 for measuring thecharacteristics within the container during the sterilization process.The measured characteristics include the temperature profile of multiplethermal masses within or outside of the container, the pressure withinor outside of the interior of the container, the length of thesterilization process, or any combination thereof. While some of theprior described sensor modules comprise sensor assemblies configured tomeasure the concentration of sterilant gases, this sensor module 692includes a sensor assembly 690 configured to measure a steam saturationstate of the steam (water vapor) to which the instruments 60 a areexposed. Saturated steam heat is one type of sterilant gas that can beused to destroy micro-organisms.

The sensor assembly 690 is configured to measure the steam saturationstate within the interior of a container 430 a similar to the previouslydescribed container 430 of FIGS. 21 and 22. More specifically, thesensor assembly 690 comprises one or more temperature sensors coupled toa corresponding one or more thermal masses that are disposed eitherwithin or outside of the container 430 a.

Referring to the schematic example illustrated in FIG. 38A, the sensorassembly 690 can comprise multiple thermal masses 702, which in thisform comprise at least a portion of multiple instruments 60 a and eachone of these instruments 60 a can have a corresponding temperaturesensor 704. More specifically, the sensor assembly 690 comprises asensor module 692 that is removably mounted to an external surface ofthe container 430 a. The module 692 has the same basic housing as themodule 570. For reasons that are apparent below, there may not be anysensors in module 692. Module 692 can include a processor 694 similar tothe processor 650. Each one of the thermal masses 702 can be locatedwithin at least a portion of the corresponding instruments 60 a, andeach thermal mass 702 comprises at least a portion of a body 698 of theinstrument 60 a. In some examples, the thermal mass is the body 698 ofthe instrument, and the temperature of no other thermal masses aremonitored other than that of the instrument. Furthermore, the sensorassembly 690 can comprise one or more temperature sensors 704 disposedinternal to the body 698 of a corresponding one of the instruments 60 a.

The temperature sensor 704 may send a signal indicative of thetemperature of the thermal masses 702 to the processor 694. Thismeasured characteristic is useful because the temperature of the thermalmass, as well as the rate of change of the temperature of the thermalmasses 702 over time, can be used to determine the state of the steam inthe environment around the thermal masses 702. In particular, becausethe thermal mass 702 is part of the instrument 60 a, the measurementsfrom the temperature sensor 704 thus provide data regarding the natureof the steam environment to which the instrument 60 a is exposed. Forexample, in some sterilization processes, for the process to beconsidered a validated process, the instrument needs to be in asaturated steam environment at a predetermined pressure for apredetermined amount of time. A saturated steam environment is one inwhich the majority of the gas in the chamber is water vapor (steam) withonly trace amounts of the gases that normally make up air. Accordingly,based on the measurements from temperature sensor 704 and/or pressuresensor, the processor 694 determines whether or not the instrument 60 ahas been exposed to threshold process conditions that ensure that adesired level of sterilization has been achieved.

Based on the signals received from the temperature sensors 704 duringthe steam sterilization process, the processor 694 determines the rateof change in temperature of the thermal masses 702, the peak temperatureof the thermal masses 702, the pressure within the container, or anycombination thereof. The processor 694 can determine whether any one ofthese measurements meet empirically determined requirements indicativeof sterilization process conditions by, for example, comparing themeasurements to data stored in a reference lookup table or a suitablealgorithm. Thus, by comparing, for example, the rate of change intemperature of the thermal mass 702 disposed within the instrument 60 awith a known rate of change for the corresponding instrument whichconfirms the state of steam saturation, the processor 694 can determinewhether the instruments have been properly sterilized. Similarly, bycomparing the peak temperature of the thermal mass 702 with a known peaktemperature which confirms validated state was achieved, the processor694 can determine if the instruments 60 a have been properly sterilized.

The temperature sensor 704 can send the signal to the processor 694 bywireless or wired transmission. In the example illustrated in FIG. 38A,the temperature sensor 704 sends the signal to the processor 694 overconductors 708, 710. In particular, the conductor 708 can extend fromthe sensor 704 through the handpiece body 698, and the other conductor710 can be coupled to the former conductor 708 and be disposed withinthe container 430 a. In other words, the conductor 710 extends from theinstrument 60 a to the module 692. Not illustrated are the terminalsthat connect conductor 708 to conductor 710 and that connect conductor710 to module processor 694.

FIG. 38B depicts another exemplary sensor module 692′ for measuringvarious characteristics within the container during the sterilizationprocess, including the temperature attributes of the single largestthermal mass within or outside of the container, the pressure within oroutside of the container, the length of the sterilization process, orany combination thereof. The sensor module 692′ comprises multiplecomponents, which are similar to those of the temperature sensor module692 of FIG. 38A and are identified by the same reference numbersfollowed by a single prime symbol (′). However, while the sensorassembly 690 of FIG. 38A comprises multiple thermal masses 702 in theform of the separate instruments 60 a including correspondingtemperature sensors 704, the sensor assembly 690′ comprises only thesingle largest thermal mass disposed within the container and one ormore temperature sensors 704′ coupled to the same. In other words, theonly temperature sensors within the sterilization container are thosecoupled to the single largest thermal mass disposed within thecontainer. In particular, the largest thermal mass can comprise thecombination of the instrument 60 a′ and the rack 62 holding theinstrument 60 a′. The temperature sensor 704′ can be a thermistor, whichis coupled to the instrument 60 a′ and the rack 62 holding theinstrument 60 a′. By measuring the thermal mass of the largest thermalmass, it can be reasonably discerned that if the largest thermal masshas reached the threshold process conditions, the smaller thermal massespresent in the container, i.e. smaller instruments, would have alsoreached the threshold process conditions.

Referring to FIG. 38C, still another exemplary sensor module 692″ cancomprise multiple components, which are similar to those of thetemperature sensor module 692 of FIG. 38A and are identified by the samereference numbers followed by a double prime symbol (″). However, whilethe sensor assembly 690 of FIG. 38A comprises multiple thermal masses702 and corresponding temperature sensors 704 within the container 430a, the sensor assembly 690″ comprises only the single largest thermalmass 702″ disposed outside of the container 430 a″ and one correspondingtemperature sensor 704″ coupled to the same. However, two or moretemperature sensors can be coupled to one or more thermal massesdisposed external to the container and within the sterilizer device.

Based on the signals received from any one or more of the temperaturesensors 704″ during the steam sterilization process, the processor 694″can determine the rate of change in temperature of the thermal mass, thepeak temperature of the thermal mass, or any combination thereof. Theprocessor 694″ can determine whether any one or more of the measuredcharacteristics meet or exceed the threshold process conditions by, forexample, comparing the measurements to data stored in a lookup table.Thus, by comparing, for example, the rate of change in temperature ofthe thermal mass or other measured characteristic with a correspondingthreshold process condition empirically determined to decontaminate theinstruments to a desired level of sterilization, the processor 694″ candetermine whether the desired level of sterilization has been achieved.Similarly, by comparing the peak temperature of the thermal mass with aknown peak temperature which confirms validated sterilizationconditions, the processor 694″ can determine if the instruments 60 a″have been exposed to the threshold process conditions. Once theprocessor 694″ has determined that the desired level of sterilizationhas been properly achieved, the processor 694″ can send a signal to oneor more notification devices to communicate the same. In some examplesand instrument configurations, additional sensors like previouslydescribed absolute pressure sensors, sterilant concentration sensors,and sterilant/gas temperature sensors (not coupled to a thermal mass)may be added to the sensor assemblies 690, 690′, and 690″ to improve thedata inputs to the processor which may improve the accuracy of measuringand determining the sterilization process conditions.

The temperature sensor can send the signal to the processor 694″ bywireless or wired transmission. In the example illustrated in FIG. 38C,the temperature sensor 704″ sends the signal to the processor 694″ overconductor 710″.

In addition to or in substitution of the electric gas concentrationsensors, the temperature sensors, and/or the pressure sensors, otherexemplary sensors can include one or more non-electric gas concentrationsensors. Examples of the non-electric gas concentration sensors caninclude a biological indicator (BI) and/or a chemical indicator (CI),which can provide the combined functions of: (1) measuringconcentrations of sterilant gases within the container; and/or (2)indicating or communicating the status of the instruments from astandpoint of desired sterile state. Alternatively, the BI and/or CI cancooperate with any one or more notification devices, as described below,such as LEDs, buttons, or other suitable notification devices, forcommunicating the status of the instruments.

The BI can comprise a collection of living spores resistant to thesterilant agent. A portion of these spores may be disposed in dry sporestrips, discs in envelopes, sealed vials or ampoules, which are exposedto the sterilant gases. Another portion of the spores can be disposed ina control sample that is not exposed to the sterilant gases. The HCPand/or a scanning device, such as a camera, can analyze the BI,temperature, pressure, and/or elapsed time to determine thesterilization condition of the container.

The BI may be configured to determine whether the most resistantmicro-organisms (e.g., Geobacillus or Bacillus species) are presentrather than merely determine whether the physical and chemicalconditions corresponding with the threshold process conditions necessaryto ensure a desired level of sterilization are satisfied. Because thespores used in BIs can be more resistant and present in greater numbersthan are the common microbial contaminants found on instruments, aninactivated BI can indicate that other less resistant pathogens on theinstruments have also been killed.

The CI can comprise chemicals that are sensitive to the sterilant gases,temperature, and/or pressure to assess the environment within thecontainer. One exemplary CI can comprise a heat-sensitive tape that isconfigured to change color rapidly when a given parameter is reached.Another exemplary CI can include a medium and an internal chemicalindicator placed at a predetermined position within the medium to ensurethat the sterilant gas has penetrated the medium and thus represent thatthe sterilant gases reached all portions of the instruments inside thecontainer. Single-parameter internal CIs can provide information on onlyone sterilization parameter and are available for steam, dry heat,and/or unsaturated chemical vapor. Multi-parameter internal indicatorscan measure two or more parameters and can provide a more reliableindication that sterilization conditions have been satisfied. Examplesof the CI can include: (1) tape, labels, and paper strips printed withan ink that changes color when exposed to one or more sterilizationparameters; and/or (2) wicking paper having one end with an ink orchemical tablet that melts and wicks along the paper over time underdesired process parameters. The wicking color from the ink or tablet canproduce a color bar that reaches a predetermined “accept” area on thepaper if proper sterilization parameters are satisfied.

As will be described below, one or more BIs and/or CIs can be: (1)disposed within the sterilization enclosure, such as the container; (2)removably coupled to an external surface of the enclosure but in fluidcommunication with the interior of the enclosure, (3) be exposed tosterilant gases propagating from the container through an airflowchallenge cannula to the BI and/or CI; (4) be disposed within the sensormodule described above. The BIs and CIs will be indicated collectivelyas a process indicator “PI”. Thus, any reference to “PI” below should beinterpreted to refer to the BI, the CI, or combinations thereof.

Referring to FIGS. 39 and 40, another example of the sensor module 570′comprises one or more PIs 57′ and is removably coupled to an externalsurface of a container 430′. This sensor module 570′ may comprisemultiple components, which are substantially similar to the componentsof the sensor module 570 as shown in FIGS. 22, 23, and 30 and areidentified by the same reference numbers as followed by a single primesymbol (′). However, while the sensor module 570 comprises twotemperature sensors 620 received in corresponding voids 616, the presentexemplary sensor module 570′ can have one or more PIs 57′ disposedbehind one or more transparent windows 53 in the sensor module 570′ (seeFIG. 40). Accordingly, the HCP can read the PIs 57′ through thetransparent windows 53. It is of course contemplated that the sensormodule 570 may include the transparent window. The shape andconfiguration of the transparent window is not particularly limited, solong as it is capable of withstanding the sterilization conditionswithin the sterilizer and maintaining the sterile environment within thesensor module when the sensor module is coupled to the sterilizationcontainer. The size and orientation of the window is not particularlylimited.

Similar to the sensor module 570, the sensor module 570′ can beaseptically and removably coupled to a normally closed valve 450′integrated in the container 430′. In particular, this container 430′ maycomprise the normally closed valve 450′, which opens when the sensormodule 570′ is coupled to the container 430′ prior to the sterilizationprocess, such that the PI 57′ is exposed to the sterilant gases in thecontainer 430′ during sterilization. In addition, the valve 450′ closesin response to the sensor module 570′ being removed from the container430′ after the sterilization process, so as to aseptically remove thesensor module 570′ from the container 430′ and prevent contaminants fromentering the container 430′ through the valve 450′.

FIG. 41 illustrates another example in which a trapdoor mechanism 750 isprovided in substitution of the normally closed valve 450′. Inparticular, the trapdoor mechanism 750 is configured to expose the PI57′ to sterilant gases within the container when the sensor module 570′is coupled to the container 430′. More specifically, the trapdoormechanism 750 can comprise a panel 436′ defining an aperture 752 and adoor 754, which is coupled to the panel 436′ and configured to move to aclosed position in order to sealingly close the aperture 752. Thetrapdoor mechanism 750 can further comprise a biasing member 756, suchas a spring, configured to move the door 754 to the closed position.Moreover, the trapdoor mechanism 750 can also comprise a lockingmechanism 758 configured to hold or lock the door 754 in the closedposition. In particular, the locking mechanism 758 can comprise a latch760, which is coupled to the panel 436′ and movable to a latchedposition such that the latch 760 holds the door in the closed position,and the biasing member 756 that moves the latch to the latched positionto sealingly close the door 754 when the sensor module 570′ is removedfrom the container 430′. The locking mechanism 758 can further comprisea handle 762 disposed within the container 430′ and configured to beaccessible only from the interior, such that a removed or contaminatedsensor module 570′ cannot be re-inserted into or re-attached to thecontainer 430′.

After the sterilization process has been completed, a HCP can analyzethe PI to determine the characteristics of the PI and thus thecharacteristics of container during the sterilization to determinewhether the instruments were exposed to threshold process conditionsthat would ensure a desired level of sterilization was achieved andcommunicate the same to the HCP. However, additional steps can beundertaken to utilize PIs for communication by other notificationdevices. In one example, the HCP can read the PI, determine thecharacteristics within the container based on the status of the PI, andmanually record the characteristics on an external surface of thecontainer. The HCP may attach a label to the external surface of thecontainer, and the label can comprise unique identification informationindicative of the sterilization conditions of the interior of thecontainer. More specifically, the HCP can use an input device to enterthe status of the PI, and a machine coupled to the user interface canprint a label comprising a bar code, a QR code, or an alphanumericidentifier corresponding with the sterilization conditions of thecontainer, and the HCP can attach the label to the container.

In other examples, a camera 65′ or other image recognition deviceconfigured to capture images of the PI can assist in determining whetherthe PI has changed state to indicate the characteristics of thecontainer during the sterilization process and/or the status of theinstruments. In particular, in examples in which the PI is not visible,such as when the PI is located inside the container and the containerdoes not include the window, the camera 65′ can capture an image of thePI or other sensor after the sterilization process before the containeris opened and the PI is accessible. In the example shown in FIG. 41, thecamera 65′ may be positioned to read the PI 57′ external to thecontainer to help identify or read the PI. A processor 67′ can becoupled to the camera 65′ to receive data corresponding with the image.The processor 67′ can compare the image with empirical data or utilizean algorithm, which is stored within memory, to determine if the stateand/or measurement of the PI or sensor corresponds with a thresholdprocess condition that would ensure the desired level of sterilization.Based on this comparison, the processor 67′ can send a signal to anysuitable notification device, as will be described below, by wireless orwired transmission to communicate the results to the container.

Referring to FIG. 42A, an exemplary container 430″ comprises a body 432″and other components, which are substantially similar to those of thecontainer 430 shown in FIG. 21 and are identified by the same referencenumbers as followed by the double prime symbol (″). However, in thisexample, the body 432″ comprises a transparent window 53′. In addition,the container 432″ further comprises a light source 55′ and a PI 57′,which are disposed within and/or coupled to the container 430″, suchthat the PI 57′ is directly exposed to sterilant gases within thecontainer 430″. The container 430″ may further comprise a holder 59′ ora mounting bracket configured to attach the PI 57′ inside the container430″ adjacent to the transparent window 53′, such that the HCP can seethe state of the PI 57′ and/or instruments within the container throughthe window 53′ without opening the lid 70″ and compromising the asepticbarrier. As described above, the location, size, orientation, andconstruction of the transparent window is not particularly limited, andthe window may be located on any of the walls and/or lid of thesterilization container.

The light source 57′ can be optionally configured to emit light at apredetermined wavelength range that optimally illuminates the PI 57′ andthe instruments positioned within the interior and provides a contrastin color to facilitate the HCP with inspecting the status of the PI 57′and the instruments through the transparent window 53′. The container430″ can further comprise one or more cells 61′ coupled to the lightsource 55′ for supplying power to the same, and a switch 63′ configuredto close a circuit comprising the cells 61′ and the light source 55′ toemit light on the PI and/or the instruments within the interior of thecontainer 430″. In certain examples, the light source 55′ may beomitted.

After the sterilization process has been completed, the PI 57′ can beanalyzed by inspection through the transparent window 53′ to determinethe sterilization conditions within the container 430″, thus serving tocommunicate the results to the HCP. In specific examples, the lightsource 55′ can be selectively actuated by the HCP, so as to assist theHCP in reading the PI 57′ and determining the sterilization processconditions within the container in view of the same, withoutcompromising the aseptic barrier.

Furthermore, the PI 57′ may be configured to measure characteristics ofthe sterilant gases entering through the container 430″ over time. Insuch an example, the container 430″ can comprise a camera 65′ or otherimage recognition device configured to capture images of the PI 57′ atpredetermined time intervals during the sterilization process, tofacilitate the HCP in determining when the PI 57′ has changed state tomeet or exceed a threshold process condition.

In particular, the camera 65′ can capture an image of the PI 57′ at atime interval at or near the end of the sterilization process. Theprocessor 67′ can be coupled to the camera 65′ to receive datacorresponding with the image. The processor 67′ can compare the imagewith empirical data or utilize an algorithm, which is stored within amemory and indicative of the state of the PI corresponding with adesired level of sterilization. Based on this comparison, the processor67′ can send a signal to any suitable notification device, as will bedescribed below, by wireless or wired transmission to communicate theresults of the container 430″.

Referring to FIG. 43, another exemplary container 50′″ may comprisemultiple components, which are substantially similar to those of thecontainer 50 of FIG. 1 and are identified by the same reference numbersfollowed by a triple prime symbol (′″). However, the container 50′″ mayfurther comprise a baffle or airflow challenge cannula 51″ that impedesthe flow or propagation of sterilant gases through the airflow challengecannula 51″ and to the PIs 57′. The cannula 51″ can be removably andaseptically coupled to the container 50′″, in any suitable fashion, andat any suitable location, such as any of the walls and/or lid of thesterilization container. The cannula 51″ may also be mounted to theexternal walls of the container. This impedance to the flow of sterilantgases improves the reliability of determining if there are acceptablesterilization process conditions, particularly because the impedancesimulates and corresponds with the sterilization of recessed portions ofthe instruments that may be comparably less exposed to the containerthan the outermost exposed surfaces of the instrument.

In particular, the cannula 51″ can comprise a conduit 61″ and a narrowor tortuous passage 55″ that impedes the propagation of sterilant gasesor steam to the PI 57′. In this example, the passage 55″ of the cannula51″ terminates at one end with a port 59″ that fluidly communicatesdirectly with the container 50′″. The passage 55″ can further comprisean opposite end communicating with the PI 57′. The PI 57′ can bedisposed along the narrow passage 55″ and spaced from the port 59″, suchthat a sterilant gas in the interior must propagate through the port 59″and at least a portion of the passage 55″ in order to reach the PI 57′.Alternatively, the PI 57′ can be located at the opposite end of thecannula 51″. Thus, in either case, the sterilant gas must displace anyair trapped in the passage 55″ to reach the PI 57′, which correspondswith the sterilant gas displacing or propagating through air trapped inthe recesses or pockets defined by surfaces of the instruments tosterilize those surfaces. The PI 57′ disposed within this passage 55″can require comparably longer times to be exposed to sterilant gas thanPIs disposed within the container or outside of the same because thosePIs are exposed directly to sterilant gases within the container and thesterilizer without requiring the sterilant gases to first propagatethrough any passage before reaching the PI. Thus, a container comprisingthe PI disposed along or at the opposite end of the narrowed passage mayrequire only a single PI because the PI disposed in the narrowed passagecan improve the reliability in determining if proper sterilizationprocess conditions obtained as compared to the PI disposed within thecontainer or the PI disposed outside of the container.

In particular, the container 50′″ can comprise a normally closed valve450′″, which is coupled to the port 59″ and removably coupled to thecannula 51″. The cannula 51″ can be removably coupled to the normallyclosed valve 450′″, which can be configured to open in response to thesame. Furthermore, the normally closed valve 450′″ is configured toclose in response to the cannula 51′ or passage 53″ or enclosurecontaining PI 57′ being removed from the valve 450′″, such that anaseptic barrier is provided.

While the PI may be used to determine if proper sterilization processconditions were achieved, the PI may be used in combination with or insubstitution of the sensors previously described.

After the sterilization process has been completed, a signalcorresponding with the status of the container and/or instrument can beelectrically or non-electrically communicated to the HCP. The sensormodule comprises one or more notification devices configured tocommunicate one or more characteristics within the container during thesterilization process and/or the status of the container and/or theinstruments to the HCP. The characteristics can include theconcentration of sterilant gases, the time of exposure to the same, thetemperature, and/or the pressure. The notification devices can becoupled to the processor and configured to communicate thecharacteristics of the container and/or status of the container and/orthe instruments, in response to receiving a signal from the processordirected to the same.

In one example, one or more notification devices can be in communicationwith the processor 384 (FIG. 11) in a manner such that one or moresensors disposed within the container can wirelessly communicate withthe processor 384 and/or the notification devices to actuate thenotification devices to communicate the characteristics within thecontainer and/or the status of the container and/or the instrumentstherein, without compromising the aseptic barrier. As but one example,the processor 384 can receive a signal from any one or more of theoptical sensor assemblies 202, 202′, 202″, 202′″ and compare themeasured concentrations of sterilant gases to empirically collected datacorresponding with sterilization process conditions. If the processor384 determines that the measured concentrations meet or exceed theempirically determined threshold process conditions that ensure adesired level of sterilization, the processor 384 can actuate LEDs 268,270 or other notification devices to communicate the status of thecontainer and/or instruments as being decontaminated to the desiredlevel of sterilization. As a further example, the processor 67′ (FIGS.41 and 42) can receive signals from the camera 65′ corresponding withcaptured images of the PI 57′ during the sterilization process. If theprocessor 67′ determines that one of those images corresponds withempirical data indicative of threshold process conditions that ensurethe desired level of sterilization, the processor can actuate the LED69′ to indicate that the instruments have been decontaminated to thedesired level of sterilization. However, the notification devices can beactuated by the HCP in response to manual inspection of the sensors orby various processors in response to signals received from any suitablesensors. Exemplary notification devices are provided below.

Referring back to FIG. 11, the exemplary sensor module 102 can comprisemultiple notification devices, which can include the two LEDs 268, 270that are coupled to the processor 384 and configured to emit lightindicative of the characteristics within the container 50 during thesterilization process and/or the status of the container and/or theinstruments therein. As one example, the LED 268 can be configured toemit red light indicative of the measured characteristics of thecontainer 50 not meeting the threshold process conditions, in responseto the LED 268 receiving a signal from the processor 384 correspondingwith this condition. Furthermore, the LED 270 can be configured to emitgreen light indicative of characteristics of the container 50 meetingthe threshold process conditions, in response to receiving a signal fromthe processor 384 corresponding with the same.

Referring to FIG. 4, each one of the LEDs 268, 270 can be seated in aseparate one of the bores 164 formed in the shell top panel 154. Morespecifically, as exemplified in FIG. 4, the LED 270 may be seated in theassociated bore 164, and O-rings 272 surround the LED 270. The O-rings272 provide a seal between the LED 270 and the adjacent, innercylindrical wall of the panel that defines the bore 164. Similarly, theLED 268 can be seated in the associated bore and surrounded bycorresponding O-rings to provide a seal between the LED 268 and theadjacent inner cylindrical wall of the panel that defines the bore 164.The LEDs 268, 270 emit different colors of light indicative of acorresponding status of the container 50 and/or the instruments. Otherexamples of the sensor module (not shown) can include any number of LEDsconfigured to emit any colored light in a steady state or intermittentpattern to indicate any characteristic of the container.

Referring to FIGS. 44A and 44B, another notification device or filterpresence notification device comprises an electro-mechanicalnotification device 1500, wherein, once it is actuated, does not requirepower and thus conserves the power of the cells 288 (FIG. 8) or otherpower source. The notification device 1500 is configured to assume atleast two different positions, one indicating an acceptable conditionand the other indicating a negative condition. More specifically, thenotification device 1500 indicating the acceptable condition canindicate that the threshold process conditions for ensuring the desiredlevel of sterilization were achieved or that the filter is present. Thenotification device 1500 indicating the negative condition can indicatethat threshold process conditions were not satisfied to ensure thedesired level of sterilization or that the filter is not present. In oneexample, the notification device comprises a button 1501 coupled to thecontainer 50. The button 1501 is movable to a raised position indicativeof the acceptable condition and a lowered position indicating theunacceptable condition. The notification device 1500 further comprises abiasing member 1502, such as a helical spring, configured to move thebutton 1501 to the raised position, and a detent 1504 configured to abutand hold the button 1501 in the lowered position. In certain examples,the notification device 1500 can further comprise an actuator 1506, suchas a solenoid, to remove the detent 1504 from the button 1501, such thatthe biasing member 1502 moves the button 1501 to the raised position inresponse to the actuator 1506 receiving a signal from the processor 384when the processor 384 determines that the acceptable condition is met,e.g. acceptable sterilization conditions have been met or via the pins276 creating an open circuit indicating that the filter medium 410 ispresent.

Referring to FIGS. 45A and 45B, another example of the mechanicalnotification device 1500′, which does not require power and thusconserves the power of the cells 288 (Figure or other power source,comprises a button 1501′, a biasing member 1502′, and other components,which are substantially similar to those of the mechanical notificationdevice 1500 and are identified by the same reference numbers followed bya single prime symbol (′). Preferably, the mechanical notificationdevice 1500′ is coupled to the container in a position that is visibleto a user when the container rests on a shelf within the sterileinventory room. However, while the biasing member 1502 shown in FIGS.44A and 44B is configured to move the button 1501 to the raisedposition, the biasing member 1502′ of the present exemplary notificationdevice 1500′ urges the button 1501′ to a lowered position. The filtermedium 410 in this example holds the button 1501′ in the raised positionto indicate the presence of the filter medium 410. Furthermore, thecontainer 50 further comprises an opening 1504′ and/or other clearancepermitting the button 1501 to move to the lowered position, so as toindicate the filter is not present. Still, other configurations of thefilter presence sensor are also contemplated.

Referring to FIG. 46, the filter medium 410 can also be detected by anon-mechanical filter detector, such as an optical filter detector 101.The optical filter detector 101 may be integrated into the container,the sensor module, or other component, as shown. The optical filterdetector 101 can transmit a signal to one of the aforementionedprocessors or other processor, which then sends a command signal to oneor both of the LEDs 268, 270 or other indicator to emit light orotherwise indicate whether the filter medium 410 is present. Theprocessor could also transmit a signal by wired or wirelesscommunication to a docking station 1000 or other location to activateother notification devices configured to communicate characteristics ofthe container including the presence of a filter. The docking station1000 may be configured to hold or carry the container on a shelf in asterile inventory room.

In other examples, the docking station 1000 can further comprise its ownfilter presence sensor 1002 configured to detect whether the containerhas a filter mounted therein. In one example, the filter presence sensor1002 can comprise an optical sensor 1004 that scans the container 430and determines if the filter medium 410 is present. The docking station1000 aligns the filter apertures 86 to the optical sensor 1004 on thedocking station 1000 such that it can determine if a filter medium 410is present.

Referring to FIG. 46, a handheld reader 2000 can be used to locate acontainer within a sterile inventory room. The handheld reader 2000comprises an optical filter detector 2002 configured to scan the lid 70to determine whether the filter medium 410 is present. Morespecifically, the optical filter detector 2002 can be aligned with oneor more apertures 86 formed in the lid 70 of the container 430 to scanthose apertures 86 and determine whether the filter medium 410 ispresent beneath the lid 70. The handheld reader 2000 can furthercomprise a processor 2004 that communicates with the processor in anyone of the container, the sensor module, and/or the docking station 1000to determine whether those components previously detected the presenceof the filter.

The container can further comprise a PI presence sensor configured todetect the presence of the PI within the closed container, within theexternal sensor module, or within the airflow challenge cannula 51″. Onenon-limiting exemplary benefit of verifying the presence of the PI isthat this ensures that only containers including the PI are delivered toa sterile operating room for a surgical procedure. In other words, thelack of the PI within the container can prevent an HCP, who is preparingfor a surgical procedure, from confirming that the instruments have beensterilized, thus requiring one or more additional containers to bedelivered to the surgical room until the HCP can verify that theinstruments have been sterilized. This can delay the surgical procedureand adversely affect the available resources of the hospital facility.

Referring to FIGS. 47A and 47B, one exemplary PI presence sensor 700 isconfigured to emit light when the PI 57′ is present. In particular, thesensor 700 can comprise two conductive pins 776 and other componentssubstantially similar to the conductive pins 276 and other components ofthe filter presence detector 209 shown in FIGS. 9 and 11. The conductivepins 776 of the PI presence sensor 700 can be urged toward a portion ofthe PI 57′ when the PI 57′ is present. In particular, the PI presencesensor 700 can include one or more springs 705 that urge the conductivepins 776 toward the PI 57′. Furthermore, a portion of the PI 57′ thatextends between the two pins 776 can include a conductive layer 702,such as a foil layer, which closes a circuit 703 when the pins 776 areurged into contact with the conductive layer 702. When the PI 57′ andits conductive layer 702 are present, the circuit is closed to indicatethe presence of the PI 57′. However, when the PI 57′ and its conductivelayer 702 are not present, the springs 705 move the pins 776 to abutagainst the non-conductive pad or shell 152, such that the circuit isopen and the LED 768 does not emit any light thus indicating that the PI57′ is not present. The circuit can further comprise a cell 788 and aLED 768, which emits light in response to the circuit being closed so asto indicate that the PI 57′ is present.

Referring to FIGS. 48A and 48B, another exemplary PI presence sensor 800is configured to emit light when the PI 57′ is absent. The sensor 800may comprise components, which are substantially similar to the presencesensor 700 of FIGS. 47A and 47B and comprise similar components asidentified by corresponding reference numerals increased by 100.However, while the PI presence sensor 700 of FIGS. 47A and 47B comprisesa conductive layer 702, the present exemplary PI presence sensor 800 iscomprised of a non-conductive material without any conductive layer.Moreover, while the sensor 700 of FIGS. 47A and 47B comprise a pair ofopposing pins 776 urged into contact with the conductive filter medium410, the sensor 800 comprises a normally closed switch 876 configured toreceive the PI 57′, which urges the switch 876 to an open position. Inthis example, the PI 57′ is comprised of non-conductive material withoutany conductive layers exposed on the exterior of the PI 57′. Thus, whenthe non-conductive PI 57′ is disposed within the switch 876, the switch876 does not close and the circuit remains open with no current beingsupplied to the notification device, which in this example is the LED868. However, when the PI 57′ is absent, the switch closes and power issupplied to the notification device, which in this form is the LED 868emitting light to indicate that the PI 57′ is absent. Of course, otherconfigurations of the PI presence sensor are contemplated.

While other exemplary containers can include speakers for communicatingthe sterilization process conditions, it may be preferred that thespeakers or other sound emitters be used for assisting the HCP infinding the container in a sterile inventory room when prompted by theHCP, as described below.

The notification device may be further configured to alert an HCP of thelocation of the container and instruments sealingly contained therein,such that the HCP can efficiently retrieve the container from a sterileinventory room and deliver the same to a sterile operating room for useduring a surgical procedure.

In addition to, or in substitution of, using LEDs to visually indicateto the HCP the status of a container, a speaker can be configured toemit a sound, such as an intermittent beep. The LEDs and speakers can becoupled to any of the cells previously described to provide powerthereto to permit the HCP to find the corresponding container and theinstruments therein. However, the LEDs and the speakers can be coupledto other power sources that are integrated in the containers, the sensormodule, or other devices to receive power from the same.

Referring again to FIG. 42A, the exemplary container 430″ can furthercomprise a remotely-detectable element 72′ configured to wirelesslycommunicate with at least one remote detecting antenna 74′ of a reader76′, such as a docking station 78′ or a hand-held wand 80′ manipulatedby the HCP. The remotely-detectable element 72′ can comprise an RFIDelement, a bar code, a QR code, or any suitable machine-readableelement, which includes unique identification information correspondingwith the container and/or the instruments disposed within the container.In one example, the unique identification information can comprise aserial number or other unique identifier. The reader 76′ can transmit asignal including data indicative of the serial number corresponding withan inventory roster of instruments within a corresponding container tobe retrieved from the sterile inventory room and delivered to a sterileoperating room where the container is opened, such that the HCP can usethe designated sterile instruments for a surgical procedure.

In one example, the notification device can comprise one or both of theLEDs 268, 270 (FIG. 11) as described above, which is further configuredto intermittently emit light to assist the HCP in finding the container50 within the sterile inventory room. Thus, once the reader 76′ is inproximity with the remotely-detectable element 72′, the LEDs 268, 270 ofthe notification device can be configured to emit light for apredetermined amount of time and then turn off as the notificationdevice enters into a sleep mode, thus conserving the power of the cells288.

The remotely-detectable element 72′ and the notification device can beintegral parts of a stand-alone device, such as a puck or disk-shapedbody, which is removably coupled to the container. However, thestand-alone device can have any suitable shape. The reader 76′ can havea memory storing the unique identification information of theremotely-detectable element 72′ with the corresponding container anddesignated instruments therein prior to the sterilization process, suchthat the data can be modified in response to the processor receivingsignals from any one of the sensors, as described above, during thesterilization process to communicate the sterilization condition of thecontainer and corresponding instruments after the sterilization processhas been completed. Furthermore, the notification device can beconfigured to receive a signal from the sensor module indicative of thesterilization process measurements or conditions, and the device can befurther configured to transmit a signal to the reader 76′, such that thereader 76′ can store the same corresponding with the uniqueidentification information. The remotely-detectable element 72′ and thenotification device can be integral parts of any one of the sensormodules as described above.

The sensor module further comprises one or more notification devicesconfigured to communicate the characteristics within the containerduring the sterilization process and/or the status of the instrumentsand/or the container. Based on the measured characteristics, theprocessor can determine if the threshold process conditions have beenmet or exceeded to ensure that the desired level of sterilization hasbeen achieved. The notification device can be any suitable notificationdevice, including any one or more of the same notification devices, asdescribed above, for communicating the sterilization process conditionsand/or location of the container. However, the sensor module cancomprise any number of other suitable notification devices.

FIG. 42B is a flow chart of a method for retrieving a sterilizationcontainer containing a desired surgical instrument. At step 4200, aretrieval command corresponding to the desired surgical instrument isinputted into a user interface. The user interface can be a tabletcomputer, a smart phone, a desktop computer, a laptop computer, or anyother suitable user interface.

At step 4202, a retrieval signal is transmitted from the user interfaceto a controller that is coupled to a database. The retrieval signalcorresponds with the retrieval command, and the retrieval signal may betransmitted through wireless or wired communication from the userinterface to the controller. In one example, the controller and thedatabase are components of a server or high performance computerconfigured to process multiple requests to retrieve containers havingdesired surgical instruments from multiple user interfaces. Morespecifically, the database has stored therein a reference tableincluding a plurality of reference retrieval commands and correspondingreference coded signals. Each one of the reference coded signals may beindicative of a container, a surgical tool contained therein, and/or astatus of the surgical instrument. Exemplary statuses of the surgicalinstrument can include sterile, contaminated, or various other statuses.

At step 4204, a coded signal corresponding with the retrieval command isdetermined. In particular, the controller can access the database andutilize the reference lookup table and the retrieval command todetermine the coded signal.

At step 4206, the coded signal is transmitted from the controller to areceiver coupled to the sterilization container containing the desiredsurgical instrument. In one embodiment, the coded signal can betransmitted to an RFID tag coupled to the sterilization container. Thesurgical instrument within the container may not have an RFID tagassociated therewith. In addition, the controller can transmit the codedsignal with sufficient power to reach the sterilization container withinan inventory room having multiple other surgical containers therein orto a sterilization container located in any portion of a hospital orother medical facility. In other embodiments, the sterilizationcontainer and/or the surgical instrument may include a receiver thatcommunicates with a protocol other than radio-frequency communication.

At step 4208, a notification device that is coupled to the sterilizationcontainer having the desired surgical instrument can be actuated inresponse to the receiver receiving the coded signal. The notificationdevice can be any of the notification devices described above, includingone or more light sources coupled to the container. In one example, thelight source can be an LED 69′ positioned external to the interior ofthe sterilization container. In another example, the light source can bean LED 55′ positioned within the interior of the container and bevisible through the transparent window 53′. The container's light sourcecan be turned on to visually indicate to the HCP the location and/orstatus of the container having the desired surgical instrument. Inaddition, the light source can illuminate the contents of theinstruments positioned within the interior of the container, such thatthe contents can be verified by manual inspection through thetransparent window 53′. This is advantageous as the contents of thesterilization container may have been mistakenly entered into the userinterface when initially loaded. Thus, if the HCP were to identify thesterilization container that supposedly included the desired surgicalinstrument, and opened that sterilization container, the HCP would notsee the desired surgical instrument. Furthermore, the misidentifiedsterilization container would no longer be sterile as it was opened bythe HCP seeking the desired surgical instrument. By visually inspectingthe contents of the sterilization container without compromisingsterility of the same, this type of resource-wasting activity can bemitigated.

These contents can include the desired surgical instrument and/or the PI57′. In one example, the controller can actuate the LED tointermittently flash on and off. In addition to, or in substitution of,using LEDs, the speaker can be actuated to emit a sound, such as anintermittent beep. The LEDs and speakers can be coupled to any of thecells previously described above to provide power thereto and permit theHCP to find the corresponding container containing the desiredinstrument.

When the contents of the container or the status of those contents ischanged, a status update command can be inputted into the userinterface, and the status update command can indicate the container, theinstrument contained within the container, and the status of theinstrument. The notification device may then be activated allowing easyretrieval of the desired sterilization container from an inventory room.The user interface can transmit a status update signal correspondingwith the status update command to the controller. The controller canupdate the reference coded signal corresponding with the surgicalinstrument and the container containing the surgical instrument.

Referring to FIG. 49A, one exemplary stand-alone sensor/notificationdevice can comprise a phase change material (PCM) device 900. The PCMdevice may be coupled to, disposed within, or adjacent to, any suitablesterilization enclosure, such as container 50. The PCM device maygenerally function to indicate the amount of heat energy that wasreceived by the phase change material disposed therein, which correlatesto the amount of heat energy that has been transferred to theinstruments present within the sterilization container by thesterilizer. This correlation may enable the HCP to determine whether theinstruments or other contents of the sterilization container havereached predetermined threshold process conditions to ensure that thedesired level of sterilization has been achieved. While one example ofsufficient heat energy for achieving predetermined standardsterilization can be 133° C. saturated steam for 4 minutes, the PCMnotification device 900 can be configured to indicate if otherconditions are present for achieving a predetermined level of steamsterilization. Furthermore, the PCM device can be used to monitorprocess conditions in any suitable device/system other than in thecontext of sterilization of surgical instruments.

As shown in FIG. 49A, the PCM device 900 includes a mounting assembly901 for attaching the PCM notification device 900 to the container. Inthis example, the PCM notification device 900 is positioned within theinterior of the container 50. In one example, the mounting assembly 901enables rotatable mounting such that the PCM device may be rotatedrelative to the sterilization container. In one configuration, themounting assembly 901 is arranged for vertical mounting of the PCMnotification device 900 to the sterilization container 50. In theillustrated embodiment, the mounting assembly 901 includes an externalplate 905 positioned external to the interior of the container, aninternal plate 907 positioned within the interior of the container. Ofcourse, other types of mounting configurations are contemplated.

Each one of the plates 905, 907 may have one or more transparent windows912 through which the PCM device 900 can be visible. Alternatively, thetransparent windows 912 can be integrated within any portion of the bodyor the lid of the container 50 to permit inspection of the PCM device900 positioned within the interior of the container 50. The transparentwindow 912 may include one or more markings that correspond to desiredsterility levels as will be described below. Furthermore, it iscontemplated that the PCM notification device 900 can be positioned inany suitable location within the interior of the container, external tothe same, or as an integral portion of any panels forming lid or thebody of the container. In addition, the PCM notification device need notbe mounted to the container, but may be merely placed within thecontainer before the container is placed into the sterilizer.

Referring to FIG. 49B, another embodiment of the PCM notification device3000 is similar to the PCM notification device 900 of FIG. 49A. However,while the PCM notification device 900 is FIG. 49A is placed within theinterior of the container 50, the PCM notification device 3000 ispositioned external to the interior of the container. As one example,the PCM notification device 3000 can be coupled to an external surfaceof the front panel or side panel. As a further example, the PCMnotification device can be a separate component positioned within thesterilizer and spaced apart from the container's walls.

Referring to FIG. 49C, still another embodiment of the PCM notificationdevice 4000 is similar to the PCM notification device 900 of FIG. 49A.While the PCM notification device 900 of FIG. 49A is placed within theinterior of the container 50, the PCM notification device 4000 is anintegral portion of the container 50. In particular, the front panel 54of the container 50 can define an opening 4002 and the PCM notificationdevice 4000 can be aseptically received within the opening 4002 andcoupled to the container 50 to sealingly block the opening 4002. Thelocation of the opening 4002 and corresponding PCM device 4000 is notparticularly limited. Furthermore, it is contemplated that the PCMdevice could be an integral component of the container, yet still berotatably mounted and be aseptically received.

The PCM notification device 900 can comprise a phase change material(PCM) 902 that undergoes a phase change and moves in a predictablemanner in response to the conditions within the container. In oneexample, the PCM device includes a phase change material that melts whenexposed to predetermined conditions, such as 133° C. saturated steam for4 minutes, so as to communicate the same to the HCP examining the phasechange notification device 900. It should be appreciated that the typeand amount of PCM utilized in the PCM device is selected to correspondto the desired conditions sought to be monitored and/or achieved. Forexample, if a higher amount of heat transfer is desired to be measured,the PCM included in the PCM device may have a higher melting point thana PCM used to measure a smaller amount of heat transfer. Along the samelines, if a higher amount of heat transfer is desired to be measured,the amount of PCM included in the PCM device may be higher than theamount of PCM used to measure a lower amount of heat transfer.

The PCM may comprise a solid-liquid phase change material, a materialthat transforms from the solid phase to the liquid phase at a definedtemperature, and absorbs energy during this process. The PCM may beselected from the group comprising a salt, such as eutectic salts, asalt-based hydrate, an organic compound, or combinations thereof. Thesalt-based hydrate may be selected from the group of hydrated calciumchloride or hydrated sodium sulphate. The organic compound may compriseparaffin. Non-limiting examples of the PCM 902 may further include urea,carbamide, carbonyldiamide, and combinations thereof. In certainembodiments, the PCM is the same color in both the melted state and thesolid state, i.e., no color change results from melting the PCM.Generally, paraffins have can have lower fusion energy than salthydrates but may not have similar challenges in repeatedly transitioningbetween solid and liquid states. While paraffin only physically changesand keeps its composition when heat is released or gained, hydrated saltchemically changes when heat is released or gained. However, the lowthermal conductivity of paraffins decreases the rate of heat stored andreleased during the melting and crystallization processes.

In some embodiments, the PCM may be configured to fully melt within anarrow temperature range, such as within a range of 10 degrees Celsiusabove or below a temperature point, within a range of 5 degrees Celsiusabove or below a temperature point, within a range of 1 degrees Celsiusabove or below a temperature point, or within a range of 0.5 degreesCelsius above or below a temperature point. In other words, in theseembodiments, the PCM fully melts within a narrow band of temperatures,such as temperature bands spanning 20, 10, 2, or 1 degrees Celsius. Insome cases, the PCM may be configured to fully melt at a sharp meltingpoint, i.e., at a discrete temperature point. Of course, the PCM may beconfigured to melt within any suitable range from any melting point.Non-limiting examples of melting ranges can include 100 to 150° C., 120to 140° C., 130 to 140° C., 130 to 135° C., 133 to 135° C., or 134 to135° C.

In still another example, the PCM can be embedded inside a graphitematrix, thus considerably increasing the heat conductivity of thecomposition without significantly reducing the energy storage. Fillermaterials other than graphite are also contemplated to be mixed with thePCM to adjust the desired thermal conductivity of the mixture and tunethe PCM notification device to indicate when certain process conditionshave been experienced by the PCM notification device, i.e., thoseprocess conditions that correlate to a desired level of sterilization.

The PCM used in the PCM notification device 900 may preferably have aspecific repeatable temperature that produces a reversible phase change,solid to liquid for example, to allow it to move or flow in apredictable manner. In another embodiment, the PCM used in the PCMnotification device 900 can be a thermoset material that undergoes anirreversible phase change.

Referring to FIGS. 50A and 50B, in another example, the PCM notificationdevice 900 can comprise a housing 903, which comprises an upper chamber904 and a lower chamber 906, and the force of gravity can transfer thePCM 902 that has undergone a phase change from the upper chamber 904 tothe lower chamber 906 to thus indicate a steam sterilization state.

The portions of the housing 903 comprising the upper and lower chambers904, 906 can be fully or partially transparent, or may includetransparent window 912 shown, such that visual inspection of the upperand lower chambers 904, 906 can reveal how much of the PCM 902 ispresent in the upper chamber and/or the lower chamber. It is alsocontemplated that any components of the PCM device, such as the housing,comprises transparent material and no distinct window is included. Anysuitable transparent component or component of the PCM notificationdevice adjacent to a transparent component may include the one or moremarkings described below.

The void space 911 (FIG. 51A) in the PCM housing assembly 903 maycomprise a specific gas or gas mixture that makes up the volume of spaceinside the PCM housing assembly that surrounds the PCM. This gas maypreferably be an inert gas, a dry gas or a gas that does not react, mixor change the PCM characteristics throughout the useful life of the PCMnotification device.

If the threshold amount of PCM has transferred to the other chamber,typically the lower chamber, it can be determined that the PCMnotification device has been exposed to the threshold process conditionsto ensure that the desired conditions have been achieved in theenvironment surrounding the PCM notification device. In certaininstances, the threshold amount is all of the PCM that is included inthe PCM device that is visually detectable. In other words, if all ofthe PCM included within the PCM device that is initially present in theupper chamber before exposure to the process, such as the sterilizer,undergoes a phase change and is now present in the lower chamber, it canbe concluded that the threshold process conditions have been achieved.The amount of phase change material included in the PCM notificationdevice may have a heat of fusion, in the aggregate, that corresponds tothe amount of heat energy necessary to achieve the threshold conditionsthat correspond to a desired level of sterilization for the surgicalinstrument included in the sterilization container.

Referring to FIGS. 51A and 51B, the PCM notification device 900 canfurther comprise a baffle 909 positioned between the upper chamber 904and the lower chamber 906 to selectively allow phase change materialthat has undergone a phase change to move from the upper chamber 904 tothe lower chamber 906 at a predetermined rate and a predetermined amountwhen the PCM device 900 has been exposed to sufficient heat energy,i.e., heat energy in an amount that correlates to the desired level ofsterility. The baffle 909 may comprise a plate (FIG. 51C), a screen, ora grating (FIG. 51B). The baffle may also be integral with the housing.

By controlling the configuration of the baffle 909, i.e., theorientation, the texture, and/or the number of openings, the rate offlow of the PCM 902 from the upper chamber 904 to the lower chamber 906can be controlled. In other words, by controlling the rate of flow fromthe upper chamber 904 to the lower chamber 906, the amount of time thatit takes for PCM 902 to move from the upper chamber 904 to the lowerchamber 906 is adjusted. The amount of time can be adjusted by changingthe configuration of the baffle 909 to match the amount of heat energynecessary to achieve the threshold process conditions that correspond tothe desired level of sterility.

Referring to FIGS. 51A and 51B, the grate 908 of the baffle 909comprises a plurality of openings 910 that allows material to move fromthe upper chamber 904 to the lower chamber 906. The size and shape ofthe opening 910 may be tuned to correspond to the size of solidparticles that can pass from the upper chamber to the lower chamber. Ifa smaller opening is provided by the baffle 909, large aggregates of PCMpresent in the upper chamber 904 cannot pass through the opening 910 inthe solid state. Thus, the opening prevents solid PCM from moving fromthe upper chamber 904 to the lower chamber 906 if the solid PCM 902 ahas dimensions larger than the opening. It is also contemplated that theopenings 910 may be sized to allow semi-solid phases to transfer fromthe upper chamber to the lower chamber.

These openings 910 can be a series of circular apertures, a series oflongitudinal slots arranged parallel to one another, or other orificeshaving any suitable shape to allow gravity flow of the PCM when in amelted, viscous or liquid state. In addition, by permitting fully meltedPCM 902 b to transfer from one chamber 904 to another chamber 906, thebaffle 909 can prevent fully melted PCM 902 b from pooling aroundunmelted portions of PCM 902 a, and influencing their ability to melt.

The size/shape of the opening(s) 910 may be configured according to thedesired rate of mass transfer desired, i.e., the rate of mass transferthat is correlated to the amount of heat transfer to achieve thresholdprocess conditions. For example, each opening 910 in the baffle 909 mayhave a width no greater than 1, 2, 3, 4 or 5 mm. In other embodiments,the opening 910 in the baffle 909 may have widths ranging from 0.1 to 5mm.

In certain embodiments, the baffle 909 takes the form of a grating 908comprising a plurality of openings 910 that are configured to preventphase change material that has not undergone a phase change from movingfrom the upper chamber 904 to the lower chamber 906. In thisnon-limiting example, the openings 910 are configured to permit PCM 902a in a liquid state or a gel state to pass from one chamber 904 toanother chamber 906, while also preventing still unmelted or onlypartially melted portions of PCM 902 exceeding a predetermined size orviscosity from passing therethrough. The number of openings and size ofthe openings is not particularly limited, so long as the size and numberof openings is tuned for PCM 902 to the desired rate of mass transfer.Furthermore, the openings in the grating may be uniform or non-uniform,i.e., the openings in one part of the grating may be different from theopenings in the other part of the grating.

Furthermore, the grating 908 can be horizontal or may be disposed at anangle that is not horizontal, (as shown in FIG. 51A) in order tofacilitate melted PCM 902 b in passing through the openings 910. Inparticular, the grating 908 can include a top surface that extends fromthe housing 903 by a non-perpendicular angle, such that the force ofgravity can pull the melted PCM 902 b across the top surface of thegrating before the PCM 902 b flows through one of the openings 910. Itis contemplated that the other embodiments, may include componentsoriented at any angle. For example, the plate or screen may also beoriented at an angle in the same way as the grating described herein.

As shown in FIG. 51B, the slanted grating 908 is a planar wallcomprising a plurality of openings 910 and disposed in a non-horizontalposition, to prevent un-melted particles of PCM 902 from transferringfrom the upper chamber 904 through the openings 910 to the lower chamber906. The slanted grating 908 can reduce the amount of fully melted PCM902 that adheres to the grating 908 thus providing a comparably highermass transfer than that with a horizontal grating. The openings 910 mayalso include chamfers, lead-ins, radius and the like to furtherfacilitate fully melted PCM 902 to pass through openings 910 whilereducing the amount that adheres to the grating. In another example,multiple gratings (not shown) symmetrically spaced above and below thecenter grating 908 can be included. These multiple gratings can alsohave different shaped and/or sized openings, similar to openings 910, tofurther regulate or stratify the size of the un-melted PCM thattransfers from the upper chamber toward the lower chamber.

Referring to FIG. 51C, another embodiment of the PCM notification device5000 can have components, which are substantially similar to thecomponents of the PCM notification device shown in FIG. 51A. The PCMnotification device 5000 includes a baffle 909′ comprising a plate 5008defining a single opening 5010 for preventing a bulk portion of thephase change material, exceeding a predetermined size and that has notundergone a phase change, from moving from the upper chamber 5004 to thelower chamber 5006. The size of opening 5010 may be advantageouslyselected to prevent PCM in the solid state from passing from the upperchamber to the lower chamber.

Referring to FIGS. 52A-52F, another example of the PCM notificationdevice 900′ can have components, which are substantially similar to thecomponents of the PCM notification device shown in FIGS. 51A and 51B andare identified by the same reference numbers followed by a single primesymbol (′). However, while the PCM notification device 900 comprises thegrating 908 and multiple openings 910 for communicating the upper andlower chambers 904, 906 with one another, the PCM notification device900′ comprises a cylindrically shaped hourglass configuration includingsingle tuned orifice 910′ through which all of the fully melted PCM 902b must pass, thus requiring that any unmelted PCM 902 a, which blocksthe orifice 910′, to melt before the entire amount of PCM 902 atransfers from one chamber 904′ to the other chamber 906′. While the PCMnotification device 900 of FIGS. 51A and 51B include the baffle in theform of the grating 908, the PCM notification device 900′ includes abaffle 909″ in the form of a tapered passage formed by the walls of thehousing that is in fluid communication between the upper chamber 904′and the lower chamber 906′.

Referring to FIGS. 52B-52F, the PCM notification device 900′ includestransparent window 912′, which allows the HCP to assess how much PCM isin the upper chamber and/or the lower chamber of the PCM notificationdevice. The transparent window 912′ may comprise one or more markings913′, 913″, 913′″ to allow the HCP to compare the amount of PCM in theupper chamber 904′ and/or the lower chamber 906′ of the PCM notificationdevice to one or more predetermined levels. It should be appreciated anyconfiguration of the PCM notification devices described above mayinclude one or more of the markings described below.

In one embodiment, referring to FIGS. 52B and 52C, the PCM notificationdevice 900′ may include a ready state marking 913′ on the upper chamber904′ correspond to a ‘ready’ state. Thus, if the PCM 902 a is present inthe amount in the upper chamber 904′ to reach the ready state marking913′, the HCP can confirm that the PCM notification device 900′ is readyto be used (See FIG. 52B), after for example the PCM notification device900′ had already been used such that at least a portion of the PCM 902 apreviously transferred from the upper chamber 904′ to the lower chamber906′. If the PCM 902 a is not present in the upper chamber 904′ in theamount sufficient to reach the ready state marking 913′, the HCP candetermine that the PCM notification device 900′ needs to be reset beforeit is ready to be used (See FIG. 52C). As can be seen in FIG. 52C, thesolid PCM in the upper chamber 904′ is not at a level that reaches theready state marking 913′, as there is some solid PCM 902 a remaining inthe lower chamber 906′. In one embodiment, the PCM notification device900′ can be placed in a sterilizer to be reset, or otherwise heated,such that enough PCM is in the upper chamber 906 to reach the readystate marking 913′.

Once the HCP confirms that the PCM notification device 900′ includesenough PCM 902 a in the upper chamber 904′ to be in the ready state, thePCM notification device 900′ and sterilization enclosure are placed inthe sterilizer for the desired sterilization cycle. Once thesterilization cycle is complete, the HCP can inspect the PCMnotification device 900′ to confirm what amount of PCM has been actuallytransferred to the lower chamber of the PCM notification device, andwhether that amount of PCM corresponds to the desired level ofsterility. To aid in this confirmation, referring to FIGS. 52D-52F, thePCM notification device 900 may further comprise one or more markings913″, 913′″ corresponding to threshold process conditions that areindicative of desired sterility levels. More particularly, eachvolumetric marking may correspond to a given amount of heat transferredto the PCM during the sterility cycle. These amounts of heat transfermay correspond to process conditions which have been validated toachieve the desired sterility levels. The sterility markings 913″, 913′″may coincide with the transparent window 912′ on the lower chamber 906′of the PCM notification device 900′.

In one exemplary configuration, the lower chamber 906′ of the PCMnotification device 900′ may include a first sterility marking 913″corresponding to a 6-log reduction in micro-organisms, and a secondsterility marking 913′″ corresponding to a 3-log reduction inmicro-organisms. When the HCP removes the sterilization container andthe corresponding PCM notification device 900′ from the sterilizer afterthe cycle has been completed, the HCP visually inspects the PCMnotification device 900′ to confirm how much of the PCM 902 b is presentin the lower chamber 906′, i.e., how much PCM melted and transferredfrom the upper chamber 904′ to the lower chamber 906′ during thesterilization cycle. If the amount of PCM 902 b in the lower chamber 906corresponds to the first sterility marking 913″ or the second sterilitymarking 913′″, the HCP can confirm that the surgical instruments havebeen exposed to the threshold process conditions that are indicative ofthe desired level of sterility. Of course, it is contemplated that anynumber of sterility markings could be included. Furthermore, it is alsocontemplated that the both the upper chamber 904′ and the lower chamber906′ can include the ready marking 913′ and the sterility markings 913″,913′″, which enables the HCP to avoid the need to re-melt the PCM beforethe PCM notification device can be re-used.

Referring specifically to FIG. 52C, after the sterilization cycle iscompleted, the HCP can inspect the PCM notification device 900′ anddetermine that the amount of PCM in the lower chamber 906′ does notreach the first sterility marking 913″, nor the second sterility marking913′″. Based on the level of PCM as compared to the sterility markings913″, 913′″, the HCP can determine that the sterilization container hasnot been exposed to the threshold process conditions that have beenvalidated to achieve the desired sterility levels.

Referring to FIG. 52D, after the sterilization cycle has been completed,some solid PCM 902 a remains within the upper chamber 904′. However, theamount of PCM present in the lower chamber 906′ is sufficient such thatthe level of PCM in the lower chamber 906′ reaches the second sterilitylevel 913′″, a 3-log reduction. This allows the HCP to confirm that theinstruments have been exposed to threshold process conditions, such asthose process conditions that have been validated to achieve the desiredlevel of sterility without opening the container.

Referring to FIG. 52E, after the sterilization cycle has been completed,all of the PCM 902 a in the PCM notification device 900′ is present inthe lower chamber 906′, and no detectable amount of PCM remains in theupper chamber 904′. Furthermore, the level of PCM 902 b in the lowerchamber 906′ corresponds to the first sterility marking 913″,corresponding to a 6-log reduction of microorganisms.

Referring now to FIG. 52F, the PCM notification device 900′ may be resetby rotating or otherwise positioning the housing 903 such that the lowerchamber 906′ is above the upper chamber 904′. Once the PCM notificationdevice 900′ is situated in this manner and the PCM notification device900′ is exposed to a sufficient amount of heat, the liquid PCM 902 b canflow from the lower chamber 906′ to the upper chamber 904′. Thus, whenthe PCM notification device 900′ is next used by the HCP, there will beenough PCM 902 in the upper chamber 904′ to correspond to the readystate marking 913′.

In one specific example, the PCM notification device 900′ could bethermodynamically sized to allow 12 cc of PCM 902 a to melt and flowinto the lower chamber 906′ when PCM notification device 900′ issurrounded by 100% saturated steam at 133° C. for 3 minutes, and furtherallows 16 cc of PCM to melt into the lower chamber 906′ when the PCMnotification device 900′ is exposed to 100% saturated steam at 133° C.for 4 minutes. In this example, each one of the transparent windows 912can include at least one marking or the plurality of graduated markingsto indicate the amount of volume and thus the corresponding time the PCMnotification device was exposed to a certain steam state for a certainamount of time, e.g. 12 cc marking for 3 minute exposure and 16 ccmarking for 4 minute exposure time.

The number and placement of graduated markings on the upper and lowerchambers is not particularly limited. It should be appreciated that suchmarkings allow the HCP to confirm whether the desired type of steamsterilant and duration of exposure has been achieved in a simple mannerthat is not prone to error. In certain embodiments, the HCP candetermine that certain process conditions have been achieved by seeingthe volume of the PCM that is present in the lower chamber as comparedto the sterility markings. This is in contrast to methods which wouldrequire the HCP to determine whether the PCM has changed color ortransparency, which can be prone to error depending on the light levelsin the area in which the PCM is inspected.

As described above with reference FIG. 52F, but now referring to FIG.51A-C, another benefit of the PCM notification device 900 is that it canbe reused after the entire amount of PCM 902 has transferred to thelower chamber 906 and PCM 902 has returned to an unmelted state, byrotating the PCM notification device 900 upside down, such that theforce of gravity and exposure to threshold steam conditions can returnor transfer fully melted PCM 902 from one end of the housing to theopposing end of the housing. Then, once cooled, the PCM in the solidstate will be located in the opposite chamber, which is in this examplethe upper chamber of the PCM notification device.

As described above, the housing 903 of the PCM device can be rotatablymounted to the interior container. In one embodiment, the PCM device maybe rotatably mounted through the circular boss 918 with the boss axiscentered on the exterior housing 903 as shown in FIG. 50A. This boss incooperation with complimentary features mounted to container side panelscan facilitate the rotation of PCM notification device 900 180° aroundthe circular boss 918 axis and position it in a ready state to bereused. The housing 903 can have any suitable shape that permits theforce of gravity to transfer PCM 902 that has undergone a phase changefrom one portion of the housing to another portion of the housing. Whilethe present example of the housing 903 comprises a rectangular prismincluding the slanted grating, it is contemplated that the grating maybe horizontal and/or the housing can have other suitable shapes.

Housing 903 components, chamber 904, chamber 906 and grating 908 can beconstructed from the same material or from different materials havingcorresponding coefficients of thermal conductivity, such that the PCMindicator 900 can be configured to indicate sterilization processconditions for various instruments and/or containers. For example, aportion of the housing 903 defining the walls adjacent to the grating908 can be made from a material having a higher coefficient of thermalconductivity than that of the portion of the housing 903 defining theupper chamber 904 that has a relatively slow heat transfer rate Q′through the chamber 904, which in turn can have a coefficient of thermalconductivity that is higher than that of the portion of the housing 903defining the lower chamber 906. However, it is contemplated that variouscombinations of any parts of the PCM indicator 900 can have higher orlower coefficients of thermal conductivity relative to one another. Inanother example, one or more layers of known suitable walls and thegrating can be made from a material that has a relatively high heattransfer rate Q through the walls.

Optional insulation materials (not shown), which have coefficients ofthermal conductivity that are higher or lower relative to one another,can be attached to one or more portions of the housing 903. Theinsulation materials can provide a very slow heat transfer rate Q″through the outside surfaces of the PCM housing 903 so as to change theamount of external surface area S where relatively high heat transferrate can occur. In one example, all portions of the housing 903 may bemade of the same material having the same coefficient of thermalconductivity, and the portion of the housing 903 adjacent to the grating908 may not include any layers of insulation material.

The portion of the housing 903 defining the upper chamber 904 can bemade of a material having a coefficient of thermal conductivity that ishigher than that of an insulation layer covering the portion of thehousing 903 that defines the lower chamber 906. The insulation layerscan overlap one another, be spaced apart from one another, or bearranged in any suitable configuration to regulate the rate of heattransfer through the housing assembly to the PCM 902. These constructiondetails, combined with the PCM 902 material thermodynamic properties,allows the PCM notification device to be specifically sized and built tocreate a repeatable thermodynamic notification system wherein a knownamount of PCM material 902 melts and thus flows into the lower chamberas a function of time for targeted steam sterilization conditions. ThePCM device housing can be a sealed housing assembly so that the PCM andthe void space 911 surrounding the PCM is sealed within the housing withproperties and a volume that remain constant throughout the useful lifeof the PCM device. Another advantage of sealing the housing assembly isto prevent ingress of pressurized fluids of the sterilization processfrom entering the interior and contaminating the PCM or causing the PCMto change its calibrated response to heat energy and temperaturechanges.

The PCM notification device 900 can be disposed at a location to whichthe flow or propagation of the sterilant gas is impeded thus increasingthe threshold by which the PCM notification device 900 determines whenthe sterilization process conditions have been achieved. In particular,the PCM notification device may replace or be joined with the PI 57′ ata bottom end of the air challenge cannula 51″. In other examples, thePCM notification device 900 can be disposed within the container. Inparticular, the PCM notification device 900 may replace or be used inconjunction with the PI 57′ inside of the container, such that the PCMnotification device 900 is disposed within the container and visiblethrough one or more transparent windows 53, 53′ (see FIG. 39). The HCPcan read the PCM notification device 900 through the window 53 withoutopening the container. In this example, the PCM notification device canbe manually reset, by turning it 180° upside down, for reuse through theopen lid prior to sealing the lid to the container base and entering thesterilization chamber. However, in still another example, the PCMnotification device 900 can be placed adjacent to the outer wall of thecontainer, such that a user can read the PCM notification device 900without having to view the same through the transparent window 53. Insuch an example, at least a portion of the PCM notification device 900is exposed to the sterilant gas within the container.

Referring to FIG. 53, a sound sensor 950 can be used in addition to orfor replacement of the sensor components described above that are usedto measure steam saturation characteristics to determine whetherthreshold process conditions have been met or exceeded to ensure thatthe desired level of sterilization has been achieved. The sound sensor950 can be configured to monitor the speed of sound through an interiorof the container to determine the steam saturation state. Based on thespeed at which sound travels through the interior, the sound sensor 950can determine the conditions present in that interior. Among otherthings, sound travels through steam at different speeds depending on thedegree of saturation of that steam. For example, sound travels through100% saturated steam faster than 50% saturated steam. In particular, oneexample of the sound sensor 950 can include a first piezoelectricemitter 952 configured to emit acoustic waves (sound) at a selectfrequency and a complementary piezoelectric receiver 954 spaced apartfrom the emitter by a known distance, such that a processor 956 candetermine the speed of the sound based upon the elapsed time from whenthe sound travels across the known distance from the emitter 952 to thereceiver 954. This type of sensor assembly is applicable because thespeed of sound in a void can vary as a function of the concentration ofa gas in the void. In this example, the speed of sound in the containercorrelates directly with the concentration of steam (water vapor) withinthe container. The processor 956 can send a signal to a notificationdevice 958 to communicate the characteristics within the containerduring the sterilization process and/or the status of the containerand/or the instruments therein, based on the speed of sound within thecontainer. The signals sent between the components of the sound sensor950 can be accomplished by wired or wireless transmission. Further, thenotification device 958 can be any one or more of the notificationdevices, as described above, or additional notification devices.

Other types of sensors are also contemplated. For instance, it iscontemplated that other types of electromagnetic sensing configurationsare also possible that can measure the speed of transmission of certaintypes of waves across the interior, including but not limited to,radiofrequency waves.

Referring to FIGS. 54A and 54B, another exemplary sterilizationcontainer 970 can include one or more sensors 972, notification devices974, and a processor 976, which are similar to any one of thoseintegrated within the first and second exemplary sterilizationcontainers 50, 430. While each one of the sterilization containers 50,430 of FIGS. 1 and 21 comprises a rigid body and a lid coupled to thebody, this exemplary container 970 comprises a tray 978 or perforatedenclosure configured to have one or more instruments 980 disposedthereon/therein and a sterile barrier wrap 982, which is ananti-microbial barrier wrapped around the instruments 980 and/or thetray 978 or perforated enclosure so as to enclose the contents in thesterile barrier wrap 982. Sterile barrier wrap 982 may have similarproperties to filter medium 410, which allows sterilant fluids (liquidsand/or gases) to penetrate the wrap into the enclosure formed by thewrap, but maintain the microbial level of the enclosed instrumentationby keeping microbes and micro-organisms from passing through the wrap.Furthermore, any one or more of the sensors, notification devices, andprocessors can be disposed within the container underneath the wrap,disposed external to the container, and/or coupled to an airflowchallenge cannula. Similar to the container 430″ of FIG. 42A comprisingthe transparent window 53′ and an LED 69′ disposed within the container430″ to permit the HCP to see the instruments and the notificationdevices therein, the wrap 982 can have a transparent window 53″ topermit the HCP to see the instruments 980 and the notification devices974 underneath the sterile barrier wrap 982. Moreover, while thenotification devices 974 comprise PIs, electronic sensors, mechanicalsensors, and PCM notification devices, the container 970 can have anyone suitable notification device or combinations thereof, such as thosedescribed above.

As best shown in FIG. 54A, the container 970 can comprise two of the PIs57′ described above. In one example, a first PI 57′ can be disposedwithin the container 970 and underneath the wrap 982. In particular, thecontainer 970 can comprise a holder 59′ coupled to the tray 978 and/orthe wrap 982, and the holder 59′ can be configured to hold the first PI57′ within the container 970. The holder 59′ can comprise a mountingbracket, a pocket, or any other suitable seat for the first PI 57′ in alocation, such that the first PI 57′ is visible through the transparentwindow 53″ and it can be read without removing the wrap 982 from thetray 978 that would potentially expose the instruments 980 tocontaminants. However, it is contemplated that the holder 59′ can holdthe first PI 57′ in any suitable location within the container 970,particularly for examples of the container that do not include thetransparent window.

The container 970 can further comprise a second PI 57′ that is removablyattached to an external surface of the container 970. In particular, anyone or more of the wrap 982, the tray 978, the second PI 57′, or asensor module containing the second PI 57′ can comprise one or moremounting mechanisms 984, that removably attach the second PI 57′ to theexternal surface of the wrap 982, such that the second PI 57′ can beread to determine the sterilization process conditions of the container970. The HCP can verify the status of the second PI 57′ by reading thefirst PI 57′ through the transparent window 53′. However, in an exampleof the container 970 that does not have the transparent window, thesecond PI 57′ can be read at or near the completion of the sterilizationprocess, and the first PI 57′ can be read to confirm sterilizationprocess conditions when the wrap 982 is removed from the tray 978 withinthe sterile operating room.

The mounting mechanism that attaches the second PI 57′ can comprisemagnetic fasteners to allow the HCP to attach and remove the second PI57′ as needed. However, other types of temporary fasteners may beutilized to attach the PI 57′ or other notification device to theoutside of the wrap, such as an adhesive, may also be utilized. Thisallows the user to determine the status of the container withoutdisrupting the sterile barrier.

The container 970 can further comprise two of the sensor modules 102 a,102 b having components that are similar to those of the sensor module102 of FIG. 3 or those of the sensor module 570 of FIG. 21, as describedabove. One of the sensor modules 102 a can be disposed underneath thewrap 982 and within the container 970, and the other sensor module 102 bcan be coupled to the external surface of the wrap 982 and/or tray 978.The sensor modules 102 a, 102 b can communicate with one another bywireless transmission and/or by wired transmission. For wirelesstransmission, the sensor modules 102 a, 102 b can have correspondingtransceivers for sending and receiving signals between each other. Forwired transmission, the sensor modules 102 a, 102 b can communicate withone another through one or more conductors (not shown) asepticallyextending through the wrap 982 and/or the tray 978. Either one or bothof the sensor modules 102 a, 102 b can further comprise the processor384 and the LEDs 268, 270 to communicate the sterilization processconditions of the container.

The PI 57′ can be removably coupled to the container 970 and fluidlycommunicate with the container 970, which in this form can be theportion of the sterile barrier wrap 982 upon which the PI 57′ ismounted. However, it is contemplated that the wrap can comprise anopening and a separate filter medium coupled to the wrap so as tosealingly cover the opening. While in one example, the PI 57′ can becoupled directly to the wrap, it is contemplated that the PI 57′ can bedisposed within a sensor module that is in turn coupled to the wrap,such that the PI 57′ is disposed outside of the container 970 andcommunicates with the interior of the same.

The filter medium 410 can challenge or impede the flow of sterilant gasfrom the container to the PI 57′, thus providing a comparably higherthreshold for evaluating the sterilization process conditions than a PI57′ disposed within the container.

Any one or more of the notification devices that are used to communicatethe sterilization process conditions of the container, as describedabove, can be integrated within the container 970 to alert the HCP ofthe location of the container with a sterile inventory room and furthercommunicate the status of its contents. As one example, the notificationdevice used to notify the HCP of the location of the container can bethe same LEDs 268, 270 used to indicate the sterilization status of thecontainer.

The alternative examples described herein may have less than all of thedescribed features. Further, features of the different versionsseparately described herein may be combined to form additional examples.For instance, the sensors that measure sterilant concentration as afunction of absorbed light may be built into any one or more of thesensor modules described herein. Furthermore, the sensors may bestand-alone devices disposed within the container and/or disposedoutside of the container but that fluidly communicate with the interiorof the container.

Accordingly, it is to be understood that the above description isintended to be illustrative and not restrictive. Many examples andapplications other than the examples provided would be apparent uponreading the above description. It is anticipated and intended thatfuture developments will occur in the technologies discussed herein, andthat the disclosed systems and methods will be incorporated into suchfuture examples. In sum, it should be understood that the application iscapable of modification and variation.

Embodiments of the disclosure can be described with reference to thefollowing numbered clauses, with specific features laid out in thedependent clauses:

-   I. A sterilization enclosure configured to be placed within a    sterilizer, the sterilization enclosure configured to accommodate a    surgical instrument for sterilization and defining an interior    capable of fluidly communicating with the sterilizer to receive    steam from the sterilizer, the sterilization enclosure comprising:

a phase change material notification device positioned within theinterior of said enclosure, said phase change material notificationdevice comprising:

a housing defining an upper chamber and a lower chamber;

a phase change material positioned within said upper chamber andconfigured to undergo a phase change and move from said upper chamber tosaid lower chamber; and

a baffle positioned between said upper chamber and said lower chamber toallow said phase change material to move from said upper chamber to saidlower chamber when a threshold amount of heat energy has beentransferred to the phase change material from the steam of thesterilizer adjacent to said phase change material notification device.

-   II. The sterilization enclosure of clause I, wherein said phase    change material notification device is rotatably coupled to said    enclosure.-   III. The sterilization enclosure of any of the preceding clauses,    wherein said phase change material notification device is rotatably    coupled to said enclosure to position said upper chamber above said    lower chamber.-   IV. The sterilization enclosure of any of the preceding clauses,    wherein said enclosure comprises a transparent window through which    at least a portion of said phase change material within said phase    change material notification device is visible.-   V. The sterilization enclosure of clause IV, wherein said enclosure    comprises a container including a body and a lid coupled to said    body, with at least one of said body and said lid having said    transparent window integrated therein.-   VI. The sterilization enclosure of clause IV, wherein said enclosure    comprises a sterile barrier wrap having said transparent window    integrated therein.-   VII. The sterilization enclosure of clause VI, wherein said sterile    barrier wrap comprises an anti-microbial barrier.-   VIII. The sterilization enclosure of any of the preceding clauses,    wherein said housing comprises a marking corresponding with at least    one of said upper chamber and said lower chamber to indicate an    amount of said phase change material located within a corresponding    one of said upper chamber and said lower chamber.-   IX. The sterilization enclosure of any of the preceding clauses,    wherein said baffle comprises an aperture, a longitudinal slot, or a    combination thereof, independently configured to prevent said phase    change material that has not undergone said phase change from moving    from said upper chamber to said lower chamber.-   X. The sterilization enclosure of any of the preceding clauses,    wherein said baffle comprises a plate, a screen, a grating, or a    combination thereof.-   XI. The sterilization enclosure of clause X, wherein said baffle    prevents a bulk portion of said phase change material that has not    undergone said phase change from moving from said upper chamber to    said lower chamber.-   XII. The sterilization enclosure of clause X, wherein said baffle    comprises a top surface and extends within a housing interior by a    non-perpendicular angle such that gravity allows a portion of said    phase change material to move along said top surface before passing    through.-   XIII. The sterilization enclosure of any of the preceding clauses,    wherein said baffle is configured to allow said phase change    material to pass therethrough when at least of a portion of said    phase change material is in a gel state, a liquid state, a viscous    state, or a combination thereof.-   XIV. The sterilization enclosure of any of the preceding clauses,    wherein said phase change material is capable of undergoing a    reversible phase change.-   XV. The sterilization enclosure of any of the preceding clauses,    wherein said phase change material is configured to melt within a    range of a temperature point.-   XVI. The sterilization enclosure of any of the preceding clauses,    such that said phase change material that has undergone said phase    change is capable of moving from said upper chamber to said lower    chamber in response to the force of gravity.-   XVII. The sterilization enclosure of any of the preceding clauses,    wherein said phase change material notification device further    comprises an insulation layer coupled to said housing.-   XVIII. The sterilization enclosure of any of the preceding clauses,    wherein said housing of said phase change material notification    device comprises a transparent window through which at least a    portion of said phase change material is visible.-   XIX. The sterilization enclosure of any of the preceding clauses,    wherein said baffle is a tapered passage in fluid communication    between said upper chamber and said lower chamber.-   XX. A sterilization enclosure configured to be placed within a    sterilizer, the sterilization enclosure for accommodating a surgical    instrument for sterilization and defining an interior capable of    fluidly communicating with the sterilizer to receive steam from the    sterilizer, the sterilization enclosure comprising:

a phase change material notification device coupled to said enclosure,said phase change material notification device comprising:

a housing defining an upper chamber and a lower chamber;

a phase change material positioned within said upper chamber andconfigured to undergo a phase change and move from said upper chamber tosaid lower chamber; and

a baffle positioned between said upper chamber and said lower chamber toallow said phase change material to move from said upper chamber to saidlower chamber when a threshold amount of heat energy has beentransferred to the phase change material from the steam of thesterilizer adjacent to said phase change material notification device.

-   XXI. The sterilization enclosure of clause XX, wherein said phase    change material notification device is positioned within said    interior of said enclosure.-   XXII. The sterilization enclosure of clause XX, wherein said phase    change material notification device is positioned external to said    interior of said enclosure.-   XXIII The sterilization enclosure of clause XX, wherein said    enclosure comprises a container, and said container defines an    opening, and said phase change material notification device is    aseptically received within said opening and coupled to said    enclosure to sealingly block said opening.-   XXIV. A phase change material notification device adapted for use    with a sterilization enclosure configured to be placed within a    sterilizer, the sterilization enclosure configured to accommodate a    surgical instrument for sterilization and defining an interior    capable of fluidly communicating with the sterilizer to receive    steam from the sterilizer, the phase change material notification    device comprising:

a housing defining an upper chamber and a lower chamber;

a phase change material positioned within said upper chamber andconfigured to undergo a phase change and move from said upper chamber tosaid lower chamber;

a marking corresponding with at least one of said upper chamber and saidlower chamber to indicate an amount of said phase change materiallocated within a corresponding one of said upper chamber and said lowerchamber; and

a baffle positioned between said upper chamber and said lower chamber toallow said phase change material to move from said upper chamber to saidlower chamber,

wherein said marking corresponds to a volume of phase change materialthat is indicative of a threshold amount of heat energy beingtransferred to the phase change material from the steam of thesterilizer adjacent to the phase change material notification device,the threshold amount of heat energy correlated to a desired level ofsterility.

-   XXV. A method for detecting a desired level of sterilization of a    sterilization enclosure placed within a sterilizer, the method    comprising:

placing the sterilization enclosure and a phase change materialnotification device within the sterilizer, the phase change materialnotification device comprising a housing that defines an upper chamberand a lower chamber, and a phase change material positioned in the upperchamber; transferring steam energy from the sterilizer to the phasechange material notification device to change a phase of at least aportion of the phase change material to enable the phase change materialto move from the upper chamber to the lower chamber;

resetting the phase change material notification device by rotating thehousing relative to the sterilization enclosure.

-   XXVI. A sterilization enclosure to be placed within a sterilizer,    and the sterilization enclosure having an interior for accommodating    at least one surgical instrument and maintaining sterility of the at    least one surgical instrument after the sterilization enclosure is    removed from the sterilizer, the sterilization enclosure comprising:

an interior and a transparent window; and

a light source coupled to said enclosure to illuminate said interior andthe at least one surgical instrument positioned within said interior,such that said interior and the at least one surgical instrument arevisible through said transparent window.

-   XXVII. A method for retrieving a sterilization enclosure containing    a desired surgical instrument, the method comprising:

inputting a retrieval command into a user interface, said retrievalcommand corresponding to the desired surgical instrument for retrieval;

transmitting a retrieval signal corresponding with said retrievalcommand from said user interface to a controller that is coupled to adatabase, said database having stored therein a plurality of referenceretrieval commands and a corresponding plurality of reference codesignals, each of said reference code signals being indicative of aenclosure and a surgical tool contained therein; and

determining a coded signal corresponding with said retrieval command;

transmitting said coded signal to a receiver coupled to thesterilization enclosure; and

-   actuating a notification device coupled to the sterilization    enclosure in response to said

receiver receiving said coded signal, such that said notification deviceindicates a location of the sterilization enclosure containing thedesired surgical instrument.

-   XXVIII. The method of clause XXVII wherein actuating said    notification device comprises illuminating a light source coupled to    the sterilization enclosure.-   XXIX. The method of any one of clauses XXVII and XXVIII, further    comprising illuminating a light source positioned within the    interior of the sterilization enclosure.-   XXX. The method of any of clauses XXVII, XXVIII, and XXIX wherein    the sterilization enclosure further includes a transparent window,    said method further comprising verifying contents positioned within    the interior of the sterilization enclosure by looking through the    transparent window.-   XXXI. The method of any of clauses XXVII, XXVIII, and XXIX wherein    the sterilization enclosure further includes a transparent window    and a process indicator, said method further comprising verifying a    status of the process indicator positioned within the interior of    the sterilization enclosure.-   XXXII. The method of any of clauses XXVII through XXXI further    comprises illuminating a light source positioned external to said    interior of the sterilization enclosure.-   XXXIII The method of any of clauses XXVIII, XXIX, and XXXII further    comprises flashing said light source on and off.-   XXXIV. The method of any of clauses XXVII through XXXIII wherein    transmitting said coded signal comprises transmitting said coded    signal to an RFID tag coupled to the sterilization enclosure.-   XXXV. The method of any of clauses XXVII through XXXIV, further    comprising placing a surgical instrument within the interior of the    sterilization enclosure and sterilizing the sterilization enclosure,    wherein the surgical instrument does not include a RFID tag    associated therewith.-   XXXVI. A sterilization container configured to be placed in a    sterilizer, and maintaining sterility of the at least one surgical    instrument after the sterilization container is removed from the    sterilizer, the sterilization container having an interior and    permitting a sterilant gas to flow from the sterilizer into the    interior, the sterilization container comprising:

at least one wall defining an interior;

a filter frame positioned within the interior, said filter frameconfigured to hold a filter medium in the interior and against saidwall; and

a sensor coupled to said filter frame and adapted to sense acharacteristic of the sterilant gas within the interior.

-   XXXVII. The sterilization container of clause XXXVI, wherein said    sensor is at least one of a gas concentration sensor, a temperature    sensor, a pressure sensor, a sound sensor, and an electromagnetic    wave transmission sensor.-   XXXVIII. The sterilization container of any of clauses XXXVI and    XXXVII, wherein said sensor comprises said gas concentration sensor.-   XXXIX. The sterilization container of any of clauses XXXVII and    XXXVIII, wherein said gas concentration sensor comprises an optical    sensor assembly configured to detect a concentration of the    sterilant gas.-   XL. The sterilization container of clause XXXIX, wherein said    optical sensor assembly comprises:

a light source and a photodetector coupled to a first portion of saidfilter frame;

a prismatic reflector coupled to a second portion of said filter frame,where said first portion and said second portion are on diametricallyopposite sides of said filter frame.

-   XLI. The sterilization container of any of clauses XXXVI through XL,    wherein said container comprises a plurality of walls, a floor, and    a lid, and at least one of said walls, said floor, and said lid    defines an aperture permitting the sterilant gas to flow from the    sterilizer and into the interior.-   XLII. The sterilization container of clause XLI, wherein said filter    frame presses said filter medium against at least one of said walls,    said floor, and said lid and adjacent to said aperture.-   XLIII. A filter module adapted for attachment to a sterilization    container configured to be placed in a sterilizer, and maintaining    sterility of the at least one surgical instrument within an interior    of the sterilization container after the sterilization container is    removed from the sterilizer, the lid assembly adapted to enclose the    interior of the sterilization container and permit a sterilant gas    to flow from the sterilizer into the interior, the filter module    comprising:

a filter medium;

a filter frame for attachment to the sterilization container andconfigured to hold said filter medium against said enclosure; and

a gas concentration sensor coupled to said filter frame and arrangedsuch that, when said filter frame is coupled to the sterilizationcontainer, said gas concentration sensor is adapted to sense aconcentration of the sterilant gas adjacent to said filter frame.

-   XLIV. The filter module of clause XLIII, wherein said filter medium    is retained by said filter frame.-   XLV. The filter module of any of clauses XLIII and XLIV, wherein    said filter frame presses said filter medium against said    sterilization container adjacent to an aperture formed in the    sterilization container.-   XLVI. The filter module of any of clauses XLIII through XLV, wherein    the sterilization container comprises a plurality of walls, a floor,    and a lid, and said aperture are formed in at least one of said    plurality of walls, said floor, and said lid.-   XLVII. The filter module of any of clauses XLII through XLVI,    wherein said gas concentration sensor comprises an optical sensor    configured to detect a concentration of the sterilant gas.-   XLVIII. A sterilization container adapted for placement within a    sterilizer and having an interior, the sterilization container    configured to hold a surgical instrument in the interior and allow a    sterilant agent to enter the interior to sterilizer the surgical    instrument, the sterilization container comprising:

a valve coupled to the enclosure and rotatable between a closed stateand an open state, said valve blocking communication between theinterior of the surgical container and an exterior of the surgicalcontainer when said valve is rotated to said closed state;

a sensor module removably coupled to said container and fluidlycommunicating through said valve with the interior of the surgicalcontainer when said valve is rotated to said open state; and

a valve locking assembly coupled to said valve and preventing said valvefrom rotating to said open state, said valve locking assembly positionedwithin and accessible only from within the interior of the surgicalcontainer.

-   XLIX. The sterilization container of clause XLVIII, wherein said    valve locking assembly is manually actuated from within the interior    of the sterilization container.-   L. The sterilization container of clause XLVIII, wherein said valve    comprises:

a valve cap having a hole fluidly communicating with the interior of thesterilization container; and

a valve plate rotatable relative to said valve cap and having a borefluidly communicating with said hole of said valve cap when said valveplate is rotated to said open state;

wherein said sensor module has a void and a sensor positioned withinsaid void, said void fluidly communicating with said bore of the valveplate, said hole of said valve cap, and the interior of thesterilization container when the valve plate is rotated to said openstate such that said void can receive a sterilant gas from the interiorof the sterilization container and said sensor measures characteristicsof said sterilant gas.

-   LI. The sterilization container of clause XLIX, wherein said bore    does not fluidly communicate with said hole when said valve plate is    rotated to said closed state, such that said valve prevents    contaminants from entering the interior of the sterilization    container.-   LII. The sterilization container of clause XLIX, wherein said valve    plate defines a channel in fluid communication between said bore of    said valve plate and said hole of said valve cap when said valve    plate is rotated to said open state, and said channel is not in    fluid communication between said bore of said valve plate and said    hole of said valve cap when said valve plate is rotated to said    closed state.-   LIII. The sterilization container of clause XLIX, wherein said    sensor module is coupled to said valve plate to rotate with said    valve plate.-   LIV. The sterilization container of clause XLIX, further comprising    a bezel plate configured to couple said sensor module to the    sterilization container when said sensor module rotates said valve    to said open state, and said bezel plate is configured to release    said sensor module from the sterilization container when said sensor    module rotates said valve to said closed state.

1. A sterilization enclosure to be placed within a sterilizer, thesterilization enclosure comprising: an interior for accommodating atleast one surgical instrument and maintaining sterility of the at leastone surgical instrument after the sterilization enclosure is removedfrom the sterilizer; a light source coupled to the enclosure toilluminate the interior and the at least one surgical instrumentpositioned within the interior; a transparent window, such that theinterior and the at least one surgical instrument are visible throughthe transparent window; and a process indicator that is either disposedwithin the interior of the sterilization enclosure or coupled to anexternal surface of the sterilization enclosure and in fluidcommunication with the interior of the sterilization enclosure such thatthe process indicator is exposed to a sterilant agent disposed withinthe interior of the sterilization enclosure.
 2. The sterilizationenclosure of claim 1, wherein the interior of the sterilizationenclosure is defined by a combination of a container body and a lid;wherein the container body comprises a plurality of walls; and whereinthe lid is removably coupled to the container body.
 3. The sterilizationenclosure of claim 2, wherein the transparent window is disposed in anopening defined by one of the plurality of walls of the container bodyor the lid.
 4. The sterilization enclosure of claim 1, wherein theprocess indicator is positioned within the interior of the sterilizationenclosure such that the process indicator is visible through thetransparent window.
 5. The sterilization enclosure of claim 1, whereinthe light source is configured to emit light at a predeterminedwavelength range that illuminates the process indicator and theinstruments positioned within the interior and provides a contrast incolor to facilitate inspection of the status of the process indicatorand the instruments through the transparent window without compromisingthe interior of the sterilization enclosure.
 6. The sterilizationenclosure of claim 1, further comprising an image recognition deviceconfigured to capture images of the process indicator at predeterminedtime intervals during a sterilization process to determine when theprocess indicator has changed state to indicate that a threshold levelof sterilization has been met or exceeded.
 7. The sterilizationenclosure of claim 1, further comprising a process indicator sensorconfigured to detect the presence of the process indicator within theinterior of the sterilization enclosure.
 8. The sterilization enclosureof claim 1, wherein the process indicator comprises at least one of abiological indicator or a chemical indicator, the process indicatorconfigured to indicate a sterile state of the instruments disposedwithin the interior of the sterilization enclosure based on a desiredsterile state.
 9. The sterilization enclosure of claim 8, wherein thebiological indicator comprises a collection of living spores resistantto the sterilant agent; and wherein the chemical indicator comprises oneor more chemicals that are sensitive to at least one of the sterilantagent, temperature, or pressure.
 10. The sterilization enclosure ofclaim 1, wherein the process indicator further comprises a notificationdevice for communicating a sterile state of the surgical instrumentdisposed within the interior.
 11. The sterilization enclosure of claim1, further comprising a notification device; a processor incommunication with the process indicator and the notification device;wherein the processor is configured to analyze data provided by theprocess indicator to determine at least one of a characteristic of theinterior, a sterile status of the interior, or a sterile status of theinstruments disposed in the interior; and wherein said processor isconfigured to provide a signal to the notification device based on thedata to actuate the notification device, such that the notificationdevice is configured to communicate at least one of the characteristicof the interior, the sterile status of the interior, or the sterilestatus of the instruments disposed in the interior to a user.
 12. Asterilization enclosure to be placed within a sterilizer, thesterilization enclosure comprising: a container body and a lid definingan interior for accommodating at least one surgical instrument andmaintaining sterility of the at least one surgical instrument after thesterilization enclosure is removed from the sterilizer; and a moduleremovably coupled to one of the container body or the lid defining theinterior, the module comprising one or more process indicators arrangedto be exposed to a sterilant agent disposed within the interior of thesterilization enclosure and a transparent window; wherein thetransparent window is disposed on the module and arranged to allow auser to observe the one or more process indicators through thetransparent window.
 13. The sterilization enclosure of claim 12, furthercomprising a light source configured to illuminate the one or moreprocess indicators such that they are visible through the transparentwindow.
 14. The sterilization enclosure of claim 12, wherein the modulecan be aseptically and removably coupled to a valve integrated into oneof the container body or the lid; wherein the valve is configured to bein an open position when the module is coupled to one of the containerbody or the lid, such that the process indicator is exposed to thesterilant agent in the interior of the sterilization enclosure; andwherein the valve is configured to be in a closed position when themodule is removed from one of the container body or the lid, so as toaseptically remove the module from the container body or the lid andprevent contaminants from entering the interior of the sterilizationenclosure through the valve.
 15. The sterilization enclosure of claim12, wherein the process indicator includes are one of a biologicalindicator or a chemical indicator, the process indicator configured toindicate a sterile state of the instruments disposed within the interiorof the sterilization enclosure based on a desired sterile state; whereinthe biological indicator comprises a collection of living sporesresistant to the sterilant agent; and wherein the chemical indicatorcomprises one or more chemicals that are sensitive to at least one ofthe sterilant agent, temperature, or pressure.
 16. A sterilizationenclosure comprising: a container defining an interior for accommodatingat least one surgical instrument to be subjected to a sterilizationprocess, the container including a transparent window; a notificationdevice disposed on the container, the notification device including alight source; a remotely detectable element removably mounted to thecontainer, the remotely detectable element includes uniqueidentification information corresponding with the container and/or thesurgical instruments disposed within the container; an antenna capableof communication with the remotely detectable element, the antennaconnected to a memory configured to store the unique identificationinformation of the remotely detectable element; and wherein thenotification device is positioned on the container such that the lightsource is visible through the transparent window when the notificationdevice is actuated; and wherein the notification device is capable ofbeing actuated to identify the container to a user based on the uniqueidentification information corresponding to at least one of thecontainer and the surgical instruments disposed within the container.17. The sterilization enclosure of claim 16, wherein the light source isconfigured to emit light at a predetermined wavelength range thatilluminates the surgical instruments positioned within the interior andprovides a contrast in color to assist the user with inspecting and/oridentifying the surgical instruments through the transparent window. 18.The sterilization enclosure of claim 16, wherein the light source isconfigured to intermittently emit light when actuated to assist the userin finding the container.
 19. The sterilization enclosure of claim 16,further comprising a process indicator that is either disposed withinthe interior of the sterilization enclosure or coupled to an externalsurface of the sterilization enclosure and in fluid communication withthe interior of the sterilization enclosure, such that the processindicator is exposed to a sterilant agent disposed within the interiorof the sterilization enclosure; and wherein the process indicatorincludes one of a biological indicator or a chemical indicator, theprocess indicator configured to indicate a sterile state of theinstruments disposed within the interior of the sterilization enclosurebased on a desired sterile state; wherein the biological indicatorcomprises a collection of living spores resistant to the sterilantagent; and wherein the chemical indicator comprises one or morechemicals that are sensitive to the sterilant agent, temperature, and/orpressure.
 20. The sterilization enclosure of claim 19, wherein theprocess indicator is positioned within the interior of the sterilizationenclosure such that the process indicator is visible through thetransparent window.